Identity
- Trade Name
- Kangaroo FDA UDI
- Generic Name
- Gastrostomy tube FDA UDI
- Device Name
- Skin Level Balloon Gastrostomy Kit FDA UDI
- Model / Reference
- 714100 EUDAMEDFDA UDI
- Description
- Skin Level Balloon Gastrostomy Kit FDA UDI
Identifiers
- Catalog Number
- 714100 FDA UDI
- Primary DI / UDI-DI
- 10884521010628 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10884521010628 EUDAMED
- FDA Product Code
- KNT FDA UDI
- EMDN Code
- G02020203 ILEOSTOMY, TUBES AND SETS EUDAMED
- GMDN Term
- Gastrostomy tube FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 14 French FDA UDILength — 1.0 Centimeter FDA UDI
714100 by Covidien llc — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10884521010628 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Covidien llc
- EUDAMED SRN
- US-MF-000017721
- Authorised Representative
- Covidien Ireland Limited IE-AR-000002274
Sources (3)
- EUDAMED a99dcb9a-929b-4e0b-b223-69219606ed17 61 fields · synced Jul 19, 2026
- FDA UDI fc38149b-8980-4d5d-8124-99eb872434eb 37 fields · synced May 29, 2026
- EUDAMED 565a8aa4-ac8f-4918-8da6-53710815b0ca 61 fields · synced Jul 19, 2026