Typesafe 2.0

GUDID 00812269031264

Typesafe 2.0 - Quantity 1000

TYPENEX MEDICAL LLC

Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD

Primary Device ID	00812269031264
NIH Device Record Key	6182c97b-f570-4a96-883f-097aa807906a
Commercial Distribution Status	In Commercial Distribution
Brand Name	Typesafe 2.0
Version Model Number	SP0201QM
Company DUNS	600850213
Company Name	TYPENEX MEDICAL LLC
Device Count	500
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	true
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812269031257 [Unit of Use]
GS1	00812269031264 [Package] Contains: 10812269031254 Package: Carton [2 Units] In Commercial Distribution
GS1	10812269031254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

BK150351

FDA Product Code

KSS	Supplies, Blood-Bank

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	2022-11-29
Device Publish Date	2022-11-21

On-Brand Devices [Typesafe 2.0]

00812269031264	Typesafe 2.0 - Quantity 1000
00812269031240	Typesafe 2.0 - Quantity 500