FDA UDI
In Commercial Distribution
🇺🇸 United States
AMT Enfit® Transition Adapter
DI: 00842071107994
·
Model: ETRN101
·
APPLIED MEDICAL TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AMT Enfit® Transition Adapter
- Primary DI
- 00842071107994
- Version / Model
- ETRN101
- Catalog Number
- ETRN101, TRN101
- Company Name
- APPLIED MEDICAL TECHNOLOGY, INC.
- Labeler DUNS
- 038101861
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 4
- Public Version Date
- 2023-07-14
- Public Version Status
- Update
- Public Device Record Key
- 2e1c928f-a40d-4d7c-8e10-2a45fb1f161d
Device Description
Male Enfit®-to-Male Luer Adapter (pouched)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PIO | Enteral Specific Transition Connectors | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64470 | ENFit/Luer linear connector | A small, non-powered, noninvasive, tubular, two-way/linear connector with an ENFit connection (designed according to ISO 80369-3 for enteral applications) at one end and a Luer connection (either lock or slip) at the other end, intended to connect an enteral device (e.g., enteral syringe, feeding tube, administration set) with ENFit connection with another device that has Luer connection. It does not incorporate a filter, valve, clamp nor tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00842071109059 | GS1 | Box (TRN101) | 10 | In Commercial Distribution | |
| Primary | 00842071107994 | GS1 |
Customer Contacts
- Phone
- (440) 717-4000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150034 | 000 |