Covidien AG

GUDID 10884522000055

TSC 12Fr Blue Tip F400(+/-0.1) Sterile

DEGANIA SILICONE LTD

Temperature-monitoring indwelling urethral drainage catheter
Primary Device ID10884522000055
NIH Device Record Key5adfeaf3-3322-4d9f-b20f-4eea853f09ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameCovidien AG
Version Model Number90055T
Company DUNS600007082
Company NameDEGANIA SILICONE LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110884522000055 [Package]
Contains: 30884522000059
Package: [12 Units]
Discontinued: 2025-04-02
Not in Commercial Distribution
GS130884522000059 [Primary]
GS190884522000051 [Package]
Package: [30 Units]
Discontinued: 2025-04-02
Not in Commercial Distribution

FDA Product Code

EZLCatheter, Retention Type, Balloon

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10884522000055]

Ethylene Oxide


[10884522000055]

Ethylene Oxide


[10884522000055]

Ethylene Oxide


[10884522000055]

Ethylene Oxide


[10884522000055]

Ethylene Oxide


[10884522000055]

Ethylene Oxide


[10884522000055]

Ethylene Oxide


[10884522000055]

Ethylene Oxide


[10884522000055]

Ethylene Oxide


[10884522000055]

Ethylene Oxide


[10884522000055]

Ethylene Oxide


[10884522000055]

Ethylene Oxide


[10884522000055]

Ethylene Oxide


[10884522000055]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-11
Device Publish Date2025-04-03

On-Brand Devices [Covidien AG]

27290110066523TSC 18Fr Blue Tip F400(+/-0.1) Sterile
27290110066509TSC 14Fr Blue Tip F400(+/-0.1) Sterile
27290110066493TSC CATHETER CLEAR 12FR STERILE
27290110066486TSC 10Fr Blue Tip F400(+/-0.1) Sterile
27290110066479TSC 8Fr Blue Tip F400(+/-0.1) Sterile
27290110066516TSC 16Fr Blue Tip F400(+/-0.1) Sterile
10884522000062TSC 14Fr Blue Tip F400(+/-0.1) Sterile
10884522000055TSC 12Fr Blue Tip F400(+/-0.1) Sterile
10884522000048TSC 10Fr Blue Tip F400(+/-0.1) Sterile
10884522000031TSC 8Fr Blue Tip F400(+/-0.1) Sterile
10884522000024TSC 18Fr Blue Tip F400(+/-0.1) Sterile
20884522000014TSC 16Fr Blue Tip F400(+/-0.1) Sterile

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