T-Cuff® 71252

GUDID 05020583712522

T-Cuff®

TERUMO BCT, INC.

Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable
Primary Device ID05020583712522
NIH Device Record Key008246d5-0e27-4a02-86ce-34827202686a
Commercial Distribution StatusIn Commercial Distribution
Brand NameT-Cuff®
Version Model Number71252
Catalog Number71252
Company DUNS801679200
Company NameTERUMO BCT, INC.
Device Count1
DM Exemptfalse
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

Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com
Phone1 877 339 4228
EmailFDAUDIprogram@terumobct.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105020583712522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCYTourniquet, Pneumatic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-15
Device Publish Date2021-06-07

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35020583700315 - Accessory Platelet Bag with Integrated Sampler2022-12-01 elabeling.terumobct.com
05020583112209 - Spectra Optia® 2022-09-01 Single-Needle Connector
05020583122208 - Spectra Optia® 2022-09-01 Exchange Sets
05020583700703 - Platelet Additive Solution Connection Adapter2022-09-01 PLATELET ADDITIVE SOLUTION CONNECTION ADAPTER
05020583705005 - COBE® Spectra 2022-09-01 Therapeutic Plasma Exchange Set

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