Anticoagulant Connection Adapter

GUDID 35020583112217

Anticoagulant Connection Adapter

TERUMO BCT, INC.

Blood transfer set Blood transfer set
Primary Device ID35020583112217
NIH Device Record Key5fbc245f-8e73-490c-a086-8d279905c49f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnticoagulant Connection Adapter
Version Model Number11221
Company DUNS801679200
Company NameTERUMO BCT, INC.
Device Count6
DM Exempttrue
Pre-market Exemptfalse
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(303)205-2510
EmailFDAUDIprogram@terumobct.com
Phone+1(303)205-2510
EmailFDAUDIprogram@terumobct.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS105020583112216 [Unit of Use]
GS135020583112217 [Primary]

FDA Product Code

GKTSeparator, automated, blood cell, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-15

On-Brand Devices [Anticoagulant Connection Adapter]

35020583112217Anticoagulant Connection Adapter
05020583112216Anticoagulant Connection Adapter

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