Warming System-catheter FPRMC00035

GUDID 07290016936230

UC-CARE LTD

Urinary catheter holder, sterile
Primary Device ID07290016936230
NIH Device Record Key9a8354d7-fd72-4d64-852a-4b62b479f074
Commercial Distribution StatusIn Commercial Distribution
Brand NameWarming System-catheter
Version Model NumberFPRMC00035
Catalog NumberFPRMC00035
Company DUNS649551124
Company NameUC-CARE LTD
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016936230 [Primary]

FDA Product Code

EZLCatheter, Retention Type, Balloon

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-05-23
Device Publish Date2017-11-15

Devices Manufactured by UC-CARE LTD

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07290016936049 - Probe sensor assembly for Hitachi V53W (square)2018-07-06
07290016936056 - Probe sensor assembly for GE E8CS (square)2018-07-06
07290016936063 - Probe sensor assembly for BK 8667 (square)2018-07-06
07290016936070 - Probe sensor assembly for MindRay2018-07-06

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