FDA.reportPublic FDA data

Covidien AG

Primary DI
27290110066516
Brand
Covidien AG
Company
DEGANIA SILICONE LTD
Model
102201101680TY
Device description
TSC 16Fr Blue Tip F400(+/-0.1) Sterile
Published
2025-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EZLCatheter, Retention Type, Balloon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZLCatheter, Retention Type, BalloonGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27290110066516PackageGS110In Commercial Distribution
47290110066510PackageGS110In Commercial Distribution
07290110066512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2729011006651627290110066516
4729011006651047290110066510
07290110066512072901100665127290110066512

GMDN Terms#

Term, Definition table
TermDefinition
Temperature-monitoring indwelling urethral drainage catheterA sterile, flexible tube with an inflatable balloon on its distal tip for retention in the urinary bladder, after its insertion through the urethra, where it functions as a long-term indwelling device for continuous urinary drainage and simultaneous monitoring of core body temperature through its integral temperature sensor, typically during or after surgery or in the presence of obstruction or paralysis. It may have a bent tip (coude) for negotiation of the prostatic curve and is typically made of silicone. It is inserted by trained staff and commonly known as a Foley catheter. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
600007082
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
true
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884522000017Covidien AG90051T2025-04-03
30884522000028Covidien AG90052T2025-04-03
30884522000035Covidien AG90053T2025-04-03
30884522000042Covidien AG90054T2025-04-03
30884522000059Covidien AG90055T2025-04-03
30884522000066Covidien AG90056T2025-04-03
20884522000014Covidien AG90051T2025-04-03
10884522000024Covidien AG90052T2025-04-03
10884522000031Covidien AG90053T2025-04-03
10884522000048Covidien AG90054T2025-04-03
10884522000055Covidien AG90055T2025-04-03
10884522000062Covidien AG90056T2025-04-03
07290110066512Covidien AG102201101680TY2025-03-04
07290110066475Covidien AG102201100880TY2025-02-20
07290110066482Covidien AG102201101080TY2025-02-20
07290110066499Covidien AG102201101280TY2025-02-20
07290110066505Covidien AG102201101480TY2025-02-20
07290110066529Covidien AG102201101880TY2025-02-20
27290110066479Covidien AG102201100880TY2025-02-20
27290110066486Covidien AG102201101080TY2025-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08886483507470Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
08886483507487Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
08886483507494Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
10192253068221DoverCardinal Health 200, LLCEZL2026-01-15
10192253068238DoverCardinal Health 200, LLCEZL2026-01-15
10192253067651DoverCardinal Health 200, LLCEZL2025-04-14
10192253067668DoverCardinal Health 200, LLCEZL2025-04-14
10192253067675DoverCardinal Health 200, LLCEZL2025-04-14
10192253067682DoverCardinal Health 200, LLCEZL2025-04-14
10192253031423DoverCardinal Health 200, LLCEZL2025-01-15
10192253031409DoverCardinal Health 200, LLCEZL2025-01-14
10192253031416DoverCardinal Health 200, LLCEZL2025-01-14
10192253038897DoverCardinal Health 200, LLCEZL2025-01-14
10192253031140DoverCardinal Health 200, LLCEZL2024-12-20
10192253031164DoverCardinal Health 200, LLCEZL2024-12-20
10192253066203DoverCardinal Health 200, LLCEZL2024-09-04
10192253066210DoverCardinal Health 200, LLCEZL2024-09-04
10192253066227DoverCardinal Health 200, LLCEZL2024-09-04
10192253066234DoverCardinal Health 200, LLCEZL2024-09-04
10192253066241DoverCardinal Health 200, LLCEZL2024-09-04
10192253066258DoverCardinal Health 200, LLCEZL2024-09-04
10192253066265DoverCardinal Health 200, LLCEZL2024-09-04
10192253066272DoverCardinal Health 200, LLCEZL2024-09-04
10192253066289DoverCardinal Health 200, LLCEZL2024-09-04
10192253066296DoverCardinal Health 200, LLCEZL2024-09-04
10192253066302DoverCardinal Health 200, LLCEZL2024-09-04
10192253066319DoverCardinal Health 200, LLCEZL2024-09-04
10192253066326DoverCardinal Health 200, LLCEZL2024-09-04
10192253066333DoverCardinal Health 200, LLCEZL2024-09-04
10192253066340DoverCardinal Health 200, LLCEZL2024-09-04