Dimension® Flex® reagent cartridge LA DF16

GUDID 00842768005398

Lactic Acid Flex® reagent cartridge, 120 tests

Siemens Healthcare Diagnostics Inc.

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Primary Device ID	00842768005398
NIH Device Record Key	000a15af-5851-4b0d-84bd-4b39a28fd0d5
Commercial Distribution Status	In Commercial Distribution
Brand Name	Dimension® Flex® reagent cartridge LA
Version Model Number	10444961
Catalog Number	DF16
Company DUNS	005088112
Company Name	Siemens Healthcare Diagnostics Inc.
Device Count	4
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)441-9250
Email	XX@XX.XX
Phone	+1(800)441-9250
Email	XX@XX.XX
Phone	+1(800)441-9250
Email	XX@XX.XX
Phone	+1(800)441-9250
Email	XX@XX.XX
Phone	+1(800)441-9250
Email	XX@XX.XX
Phone	+1(800)441-9250
Email	XX@XX.XX
Phone	+1(800)441-9250
Email	XX@XX.XX
Phone	+1(800)441-9250
Email	XX@XX.XX
Phone	+1(800)441-9250
Email	XX@XX.XX
Phone	+1(800)441-9250
Email	XX@XX.XX
Phone	+1(800)441-9250
Email	XX@XX.XX
Phone	+1(800)441-9250
Email	XX@XX.XX
Phone	+1(800)441-9250
Email	XX@XX.XX
Phone	+1(800)441-9250
Email	XX@XX.XX
Phone	+1(800)441-9250
Email	XX@XX.XX
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)441-9250
Email	CONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414004440 [Unit of Use]
GS1	00842768005398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K914508

FDA Product Code

KHP	ACID, LACTIC, ENZYMATIC METHOD

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-10-02
Device Publish Date	2020-09-24

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00630414624518 - Atellica IM TSH3-Ultra II	2024-05-30 TSH3-ULII Atellica IM - RGT 110T
00630414624525 - Atellica IM TSH3-Ultra II	2024-05-30 TSH3-ULII Atellica IM – RGT 550T
00630414624532 - Atellica IM TSH3ULII MCM set	2024-05-30 TSH3-ULII Atellica IM - Consumable MCM Set
00630414624693 - Atellica IM TSH3-Ultra II	2024-05-30 TSH3-ULII Atellica IM - RGT (REF) 2750T
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00630414317434 - Clinistix Kidney Health Test System	2024-05-13 Test Strips for the Determination of Albumin and Creatinine in Urine

Trademark Results [Dimension]

Mark Image Registration \| Serial	Company Trademark Application Date
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DIMENSION 97501679 not registered Live/Pending	Danqi Shen 2022-07-13
DIMENSION 97078680 not registered Live/Pending	American Pacific Industries, Inc. 2021-10-18
DIMENSION 90657575 not registered Live/Pending	Ruggable LLC 2021-04-20
DIMENSION 90546735 not registered Live/Pending	Unique Sales and Marketing 2021-02-25
DIMENSION 88897959 not registered Live/Pending	Grail, Inc. 2020-05-01
DIMENSION 88782203 not registered Live/Pending	LaVita, David,A 2020-02-02
DIMENSION 88781686 not registered Live/Pending	Konami Gaming, Inc. 2020-01-31
DIMENSION 88390527 not registered Live/Pending	Amendia, Inc. 2019-04-17