ClearCRIT Self-Sealing ®Mylar®Wrapped Capillary Tubes 270-109

GUDID 00831829000328

SEPARATION TECHNOLOGY, INC.

Capillary blood collection tube IVD, ammonium heparin
Primary Device ID00831829000328
NIH Device Record Key470d038b-c683-462c-a49d-a49dfb2850e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearCRIT Self-Sealing ®Mylar®Wrapped Capillary Tubes
Version Model Number270-109
Catalog Number270-109
Company DUNS195501127
Company NameSEPARATION TECHNOLOGY, INC.
Device Count20
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Phone18005315535
Emailstanbiolab@ekfdiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100831829000328 [Primary]
GS100831829000335 [Unit of Use]

FDA Product Code

GIOTube, Collection, Capillary Blood

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-08-09
Device Publish Date2017-08-25

On-Brand Devices [ClearCRIT Self-Sealing ®Mylar®Wrapped Capillary Tubes ]

00831829000403270-109VL
00831829000328270-109

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