Identity
- Trade Name
- AbbVie J FDA UDI
- Generic Name
- Jejunostomy tube FDA UDI
- Device Name
- The AbbVie J is a 9 FR intestinal (J) tube, 120 cm in length. AbbVie J Tube for 15 FR PEG kit (List Number 62918-001) AbbVie J Tube for 20 FR PEG kit (List Number 0AV062-001) This kit includes (Fig. 1): - AbbVie J Tube with Teflon coated Guide Wire and Blue Guide Wire Lock - Y-Connector for the 15 FR PEG or 20 FR PEG - Fixation Screw (blue: 15 FR or violet: 20 FR) with Outer Ring - Click Adaptor consisting of: - Click Adaptor Cap - Click Adaptor Connector FDA UDI
- Model / Reference
- 62918 FDA UDI
- Description
- The AbbVie J is a 9 FR intestinal (J) tube, 120 cm in length. AbbVie J Tube for 15 FR PEG kit (List Number 62918-001) AbbVie J Tube for 20 FR PEG kit (List Number 0AV062-001) This kit includes (Fig. 1): - AbbVie J Tube with Teflon coated Guide Wire and Blue Guide Wire Lock - Y-Connector for the 15 FR PEG or 20 FR PEG - Fixation Screw (blue: 15 FR or violet: 20 FR) with Outer Ring - Click Adaptor consisting of: - Click Adaptor Cap - Click Adaptor Connector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08054083004860 FDA UDI
- 510(k) Number
- K142816 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Jejunostomy 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
MR Conditional FDA UDI
Category: Jejunostomy tube
AbbVie J by Abbvie Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Jejunostomy tube.
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- AVANOS — Avanos Medical, Inc. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
- Halyard — Avanos Medical, Inc. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
Cleared under the same submission
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 0aaacff7-4c44-4643-9bc9-f3d93b3a8ac4 34 fields · synced Jun 6, 2026