FDA UDI
In Commercial Distribution
🇺🇸 United States
ENFit Pharm Cap
DI: 00350770000459
·
Model: PC-INC
·
Avanos Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Basic Information
- Brand Name
- ENFit Pharm Cap
- Primary DI
- 00350770000459
- Version / Model
- PC-INC
- Catalog Number
- PC-INC
- Company Name
- Avanos Medical, Inc.
- Labeler DUNS
- 079375431
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2021-04-29
- Public Version
- 2
- Public Version Date
- 2023-06-22
- Public Version Status
- Update
- Public Device Record Key
- d8e1210b-19ee-4d88-a0e1-2c746d3bfecf
Device Description
ENFit Pharm Cap Size I NonSterile Purp
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KYX | DISPENSER, LIQUID MEDICATION | General Hospital | 880.6430 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16617 | Medicine bottle cap | A sturdy covering designed to close off and seal the top of a medicine bottle providing protection from the external environment. It will typically consist of a plastic cover that may include a glued or cemented liner/seal, e.g., rubber or plastic. Some devices are threaded for screwing on to the bottle. Medicine bottle caps are frequently made with a built-in safety feature locking mechanism making them child proof, e.g., require a push-down/screw action to open. This device is reusable until the contents of the bottle are exhausted. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10350770000456 | GS1 | CS | 16 | In Commercial Distribution | |
| Primary | 00350770000459 | GS1 | ||||
| Unit of Use | 20350770000453 | GS1 |
Customer Contacts
- Phone
- +1(844)428-2667
- [email protected]