Identity
- Trade Name
- AbbVie PEG FDA UDI
- Generic Name
- Gastrostomy tube FDA UDI
- Device Name
- The AbbVie PEG is a percutaneous endoscopic gastrostomy (PEG, or gastric) tube, either 15 FR or 20 FR and 35 cm in length. The kit includes the following (Fig. 1): - AbbVie PEG Tube (polyurethane) - Reel of Thread with double thread and Introducer Device - Puncture Cannula with safety (air) valve - Disposable Scalpel - Silicone external Fixation Plate (radio-opaque) with integrated Tube Clip (blue of AbbVie PEG 15 FR, violet for AbbVie PEG 20 FR) - Tube Clamp FDA UDI
- Model / Reference
- 62910 FDA UDI
- Description
- The AbbVie PEG is a percutaneous endoscopic gastrostomy (PEG, or gastric) tube, either 15 FR or 20 FR and 35 cm in length. The kit includes the following (Fig. 1): - AbbVie PEG Tube (polyurethane) - Reel of Thread with double thread and Introducer Device - Puncture Cannula with safety (air) valve - Disposable Scalpel - Silicone external Fixation Plate (radio-opaque) with integrated Tube Clip (blue of AbbVie PEG 15 FR, violet for AbbVie PEG 20 FR) - Tube Clamp FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08054083004952 FDA UDI
- 510(k) Number
- K142793 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Gastrostomy tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Category: Gastrostomy tube
AbbVie PEG by Abbvie Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrostomy tube.
- Balloon G-Tube — Applied Medical Technology, Inc. · Class II
- Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection — Xeridiem Medical Devices · Class II
- 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
- Kangaroo — Cardinalhealth · Class II
- Gastrostomy Tube — Hangzhou Fushan Medical Appliances Co., Ltd. · Class IIa
- EndoVive™ Low Profile Replacement Button — Boston Scientific · Class II
Cleared under the same submission
K142793 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Abbvie Inc.
Sources (1)
- FDA UDI a1bd8ee0-72e5-4541-a9dc-37a3d9882656 34 fields · synced May 30, 2026