Duns Number:078458370
Device Description: The AbbVie PEG is a percutaneous endoscopic gastrostomy (PEG, or gastric) tube, either 15 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
Catalog Number
-
Brand Name
AbbVie PEG
Version/Model Number
62912
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K142793
Product Code
KNT
Product Code Name
Tubes, Gastrointestinal (And Accessories)
Public Device Record Key
22288747-a382-499e-935e-c5b91b9b5f4b
Public Version Date
April 20, 2020
Public Version Number
3
DI Record Publish Date
April 15, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |