Duns Number:078458370
Device Description: The AbbVie J is a 9 FR intestinal (J) tube, 120 cm in length. AbbVie J Tube for 15 FR PEG 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
Catalog Number
-
Brand Name
AbbVie J
Version/Model Number
62918
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K142816
Product Code
KNT
Product Code Name
Tubes, Gastrointestinal (And Accessories)
Public Device Record Key
0aaacff7-4c44-4643-9bc9-f3d93b3a8ac4
Public Version Date
October 07, 2019
Public Version Number
2
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 |