AbbVie PEG
The AbbVie PEG is a gastrostomy tube that provides long term access for medication delivery to the small intestine when used with an AbbVie J intestinal tube. It is indicated for…
The AbbVie PEG is a gastrostomy tube that provides long term access for medication delivery to the small intestine when used with an AbbVie J intestinal tube. It is indicated for administration of DUOPA, a carbidopa and levodopa enteral suspension.
The polyurethane PEG tube passes through the abdominal wall into the stomach, and the intestinal tube passes through it to reach the small intestine. Available PEG sizes are 15 or 20 French, both 35 cm long.
Listed Item
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
Kit and Gastric Feeding
The sterile kit includes an external fixation plate with tube clip, a clamp and placement accessories. Enteral nutrition can be delivered directly into the stomach when needed alongside intestinal medication delivery. The external plate is silicone and radiopaque.
Who Else Makes It
Concentrated in Jiangsu (17), Zhejiang (4), Guangdong (2). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 18 |
| Mcreat ( Guangzhou ) BIO-Tech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 14 |
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Tessy Plastics Shanghai Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Flexan (Suzhou) Precision Rubber Products Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 1 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
Showing 12 of 25. All 25 manufacturers in China registered for Tubes, Gastrointestinal (And Accessories)
Record
| Listed by | AbbVie Inc, United States |
|---|---|
| FDA product code | KNT |
| Device type | Tubes, Gastrointestinal (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K142793 |
| Record published | 2019-04-15 |
| Record revised | 2020-04-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 62910 | In distribution | |
| 62912 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Avanos | Avanos Medical, Inc. | 1,169 |
| Halyard | Avanos Medical, Inc. | 1,004 |
| G-Jet® Transgastric-Jejunal Feeding Device | Applied Medical Technology, Inc. | 376 |
| MiniONE Balloon Button | Applied Medical Technology, Inc. | 373 |
| Mini ONE® Balloon Button | Applied Medical Technology, Inc. | 336 |
| Kangaroo | Cardinal Health | 326 |
| NutraGlide Nasal Feeding Tube | Applied Medical Technology, Inc. | 279 |
| AMT Mini™ Balloon Button | Applied Medical Technology, Inc. | 231 |
| Vygon | Vygon Corp. | 229 |
| NeoDevices, Inc. | Neodevices Inc | 123 |
| Corflo cuBBy Lpgd | Corpak Medsystems | 98 |
| Kangaroo | Cardinal Health 200, LLC | 98 |
Showing 12 of 457. All products under Tubes, Gastrointestinal (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142793 | 2015-01-14 |
| K142792 | 2015-01-14 |
| K142816 | 2015-01-14 |
| K133087 | 2014-06-19 |
| K133129 | 2014-06-19 |
| K133096 | 2014-06-18 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| AbbVie US LLC | 510(k) number | 2017-04-27 | Class II | Under Investigation by firm | 673 kits | 2019-07-09 | |
| AbbVie US LLC | 510(k) number | 2017-04-27 | Class II | Under Investigation by firm | PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information. | 2019-07-09 | |
| AbbVie US LLC | 510(k) number | 2017-04-27 | Class II | Under Investigation by firm | PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information. | 3,331 kits | 2019-07-09 |
| AbbVie US LLC | 510(k) number | 2016-11-22 | Class II | Device Design | AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the AbbVie 20FR PEG tube from the Y-connectors. | 541 units | 2019-07-09 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.