FDA UDI
In Commercial Distribution
🇺🇸 United States
Covidien AG
DI: 07290110066512
·
Model: 102201101680TY
·
DEGANIA SILICONE LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Covidien AG
- Primary DI
- 07290110066512
- Version / Model
- 102201101680TY
- Company Name
- DEGANIA SILICONE LTD
- Labeler DUNS
- 600007082
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-04
- Public Version
- 1
- Public Version Date
- 2025-03-12
- Public Version Status
- New
- Public Device Record Key
- d7f83864-9cae-4922-ab78-7f7e15b61e16
Device Description
TSC 16Fr Blue Tip F400(+/-0.1) Sterile
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- Yes
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | 876.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46629 | Temperature-monitoring indwelling urethral drainage catheter | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 27290110066516 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 07290110066512 | GS1 | ||||
| Package | 47290110066510 | GS1 | Carton | 10 | In Commercial Distribution |