FDA UDI
In Commercial Distribution
🇺🇸 United States
AVANOS
DI: 00350770001722
·
Model: 8301-60
·
Avanos Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AVANOS
- Primary DI
- 00350770001722
- Version / Model
- 8301-60
- Catalog Number
- 8301-60
- Company Name
- Avanos Medical, Inc.
- Labeler DUNS
- 079375431
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-30
- Public Version
- 1
- Public Version Date
- 2021-02-08
- Public Version Status
- New
- Public Device Record Key
- 03f19b36-0d94-4557-9881-675ca49c4331
Device Description
MIC* FEEDING PORT WITH ENFIT CONNECTOR
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
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KNT | Tubes, gastrointestinal (and accessories) | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64471 | ENFit/ENFit 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 both ends intended to connect two enteral devices (e.g., enteral syringe, feeding tube, administration set) with each other; it does not have a Luer connection(s) (neither lock nor slip), and 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 | 10350770001729 | GS1 | CS | 5 | In Commercial Distribution | |
| Primary | 00350770001722 | GS1 |
Customer Contacts
- Phone
- +1(844)428-2667
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 14 | French | |
| Device Size Text, specify | Outer Diameter |