CRTG 304-07POR PORC HMS ORG 5L INT 9PK Medical Device Identification

GUDID 00643169713208

CRTG 304-07POR PORC HMS ORG 5L INT 9PK

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	00643169713208
NIH Device Record Key	9a88307e-d52a-4d24-b1ca-c80dc3c0298b
Commercial Distribution Status	In Commercial Distribution
Version Model Number	304-07POR
Company DUNS	006261481
Company Name	MEDTRONIC, INC.
Device Count	9
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

Device Dimensions

Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, Specify	Between 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, Specify	Between 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, Specify	Between 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, Specify	Between 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, Specify	Between 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, Specify	Between 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, Specify	Between 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, Specify	Between 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, Specify	Between 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, Specify	Between 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, Specify	Between 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, Specify	Between 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, Specify	Between 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, Specify	Between 0 and 0 *Refrigerated 2°C-10°C
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature 10°C-25°C
Special Storage Condition, Specify	Between 0 and 0 *Refrigerated 2°C-10°C

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169713208 [Unit of Use]
GS1	20643169713202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K894317

FDA Product Code

JOX	ANALYZER, HEPARIN, AUTOMATED

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	2023-04-08

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