ClearCrit Mylar®Coated Glass Capillary Tubes 270-108

GUDID 00831829000304

SEPARATION TECHNOLOGY, INC.

Capillary blood collection tube IVD, ammonium heparin
Primary Device ID00831829000304
NIH Device Record Key4699f63f-8d5e-4b8c-8527-6083732b6eee
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearCrit Mylar®Coated Glass Capillary Tubes
Version Model Number270-108
Catalog Number270-108
Company DUNS195501127
Company NameSEPARATION TECHNOLOGY, INC.
Device Count5
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
GS100831829000304 [Primary]
GS100831829000311 [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

Devices Manufactured by SEPARATION TECHNOLOGY, INC.

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00831829000267 - ClearCRIT® Plastic Capillary Tubes2018-08-09
00831829000281 - ClearCRIT® Plastic Capillary Tubes2018-08-09
00831829000304 - ClearCrit Mylar®Coated Glass Capillary Tubes 2018-08-09
00831829000304 - ClearCrit Mylar®Coated Glass Capillary Tubes 2018-08-09
00831829000328 - ClearCRIT Self-Sealing ®Mylar®Wrapped Capillary Tubes 2018-08-09
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