CARTRIDGE 402-07 HR HTC BXD 11L 20BX Medical Device Identification

GUDID 00763000441456

CARTRIDGE 402-07 HR HTC BXD 11L 20BX

MEDTRONIC, INC.

Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic Heparin anti-Xa IVD, kit, chromogenic

Primary Device ID	00763000441456
NIH Device Record Key	678d77b9-444f-4d49-9882-2184600283ea
Commercial Distribution Status	In Commercial Distribution
Version Model Number	402-07
Company DUNS	006261481
Company Name	MEDTRONIC, INC.
Device Count	20
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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
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)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *HR HTC should be stored in a stable environment, either at 2°C to 10°C (36°F to 50°F), or 10°C to 25°C (50°F to 77°F).
Special Storage Condition, Specify	Between 0 and 0 *HR HTC should be stored in a stable environment, either at 2°C to 10°C (36°F to 50°F), or 10°C to 25°C (50°F to 77°F).
Special Storage Condition, Specify	Between 0 and 0 *HR HTC should be stored in a stable environment, either at 2°C to 10°C (36°F to 50°F), or 10°C to 25°C (50°F to 77°F).
Special Storage Condition, Specify	Between 0 and 0 *HR HTC should be stored in a stable environment, either at 2°C to 10°C (36°F to 50°F), or 10°C to 25°C (50°F to 77°F).
Special Storage Condition, Specify	Between 0 and 0 *HR HTC should be stored in a stable environment, either at 2°C to 10°C (36°F to 50°F), or 10°C to 25°C (50°F to 77°F).
Special Storage Condition, Specify	Between 0 and 0 *HR HTC should be stored in a stable environment, either at 2°C to 10°C (36°F to 50°F), or 10°C to 25°C (50°F to 77°F).
Special Storage Condition, Specify	Between 0 and 0 *HR HTC should be stored in a stable environment, either at 2°C to 10°C (36°F to 50°F), or 10°C to 25°C (50°F to 77°F).
Special Storage Condition, Specify	Between 0 and 0 *HR HTC should be stored in a stable environment, either at 2°C to 10°C (36°F to 50°F), or 10°C to 25°C (50°F to 77°F).
Special Storage Condition, Specify	Between 0 and 0 *HR HTC should be stored in a stable environment, either at 2°C to 10°C (36°F to 50°F), or 10°C to 25°C (50°F to 77°F).
Special Storage Condition, Specify	Between 0 and 0 *HR HTC should be stored in a stable environment, either at 2°C to 10°C (36°F to 50°F), or 10°C to 25°C (50°F to 77°F).
Special Storage Condition, Specify	Between 0 and 0 *HR HTC should be stored in a stable environment, either at 2°C to 10°C (36°F to 50°F), or 10°C to 25°C (50°F to 77°F).
Special Storage Condition, Specify	Between 0 and 0 *HR HTC should be stored in a stable environment, either at 2°C to 10°C (36°F to 50°F), or 10°C to 25°C (50°F to 77°F).
Special Storage Condition, Specify	Between 0 and 0 *HR HTC should be stored in a stable environment, either at 2°C to 10°C (36°F to 50°F), or 10°C to 25°C (50°F to 77°F).
Special Storage Condition, Specify	Between 0 and 0 *HR HTC should be stored in a stable environment, either at 2°C to 10°C (36°F to 50°F), or 10°C to 25°C (50°F to 77°F).
Special Storage Condition, Specify	Between 0 and 0 *HR HTC should be stored in a stable environment, either at 2°C to 10°C (36°F to 50°F), or 10°C to 25°C (50°F to 77°F).

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000441456 [Unit of Use]
GS1	20763000441450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K902081

FDA Product Code

JBP	ACTIVATED WHOLE BLOOD CLOTTING TIME

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	2023-04-17
Device Publish Date	2023-04-07

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