Identity
- Trade Name
- Kangaroo FDA UDI
- Generic Name
- Gastrostomy tube FDA UDI
- Device Name
- Kangaroo Skin Level Balloon Gastrostomy Kit, 18 Fr/Ch (6.0 mm) x 1.2 cm EUDAMEDSkin Level Balloon Gastrostomy Kit FDA UDI
- Model / Reference
- 718120 EUDAMEDFDA UDI
- Description
- Skin Level Balloon Gastrostomy Kit FDA UDI
Identifiers
- Catalog Number
- 718120 FDA UDI
- Primary DI / UDI-DI
- 10884521011113 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10884521011113 EUDAMED
- FDA Product Code
- KNT FDA UDI
- EMDN Code
- G02020201 GASTROSTOMY, 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
- Length — 1.2 Centimeter FDA UDICatheter Gauge — 18 French FDA UDI
Category: Gastrostomy tube
Kangaroo by Cardinalhealth — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Gastrostomy tube.
- Balloon G-Tube — Applied Medical Technology, Inc. · Class II
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- AMT Balloon G-Tube — Applied Medical Technology, Inc. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
- Low-Profile Gastrostomy Replacement Tube (G. Button) Kit — Sky Medical a.s. · Class IIb
- Gastrostomy Tube — Hangzhou Fushan Medical Appliances Co., Ltd. · Class IIa
- EndoVive™ Low Profile Replacement Button — Boston Scientific · Class II
- AMT Capsule Dome G-Tube — Applied Medical Technology, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cardinalhealth
Sources (2)
- FDA UDI 66d1d2de-404f-46aa-b4b1-8f01a87a286c 37 fields · synced Jul 12, 2026
- EUDAMED 1af28dfc-84e3-45fa-8368-3f57d23f05e7 61 fields · synced Jul 12, 2026