AMT MiniONE Extension Set E8-2455-ISOSAF
by Applied Medical Technology, Inc. 2 variants
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00842071153144 | Date13 May 2026 | StatusListed |
Recalls
-
- Completed Z-0819-2025
The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit with other ENFit-compatible devices, and will not fit with non-ENFit connectors.
-
- Terminated Z-1497-2016
The firm received complaints that the product is shorter in length than indicated on the label.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- AMT MiniONE Extension Set
- Generic Name
- Enteral tube extension, single-use
- Model / Ref / Catalog
- E8-2455-ISOSAF, 8-2455-ISOSAF
- Primary DI / UDI-DI
- 00842071153144
- FDA Product Code
- KNT, PIF
- GMDN Term
- Enteral tube extension, single-use
- Device Class
- Class II
- Regulation Number
- 876.5980
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 24 Inch
Other devices from Applied Medical Technology, Inc.
Properties
Other properties (10)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No