Mission Plus Hemoglobin (Hb) Optical Verifier

GUDID 20682607610567

Box of 2 Optical Verifiers (1 vial)

ACON LABORATORIES, INC.

Haemoglobin analyser IVD, point-of-care Haemoglobin analyser IVD, point-of-care
Primary Device ID20682607610567
NIH Device Record Key9da8ada0-4f30-46e4-9ba1-617c2a6100fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameMission Plus Hemoglobin (Hb) Optical Verifier
Version Model NumberC122-3021
Company DUNS781100966
Company NameACON LABORATORIES, INC.
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100682607000241 [Unit of Use]
GS100682607610563 [Primary]
GS120682607610567 [Package]
Contains: 00682607610563
Package: carton [200 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKRSYSTEM, HEMOGLOBIN, AUTOMATED

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [Mission Plus Hemoglobin (Hb) Optical Verifier]

20682607610567Box of 2 Optical Verifiers (1 vial)
00682607000203Vial of 2 Optical Verifiers

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