FDA UDI
In Commercial Distribution
🇺🇸 United States
Enteral Feeding
DI: 00020451101453
·
Model: ENFMEDCAPLD
·
MEDELA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- Enteral Feeding
- Primary DI
- 00020451101453
- Version / Model
- ENFMEDCAPLD
- Company Name
- MEDELA, INC.
- Labeler DUNS
- 052002029
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 5
- Public Version Date
- 2023-11-09
- Public Version Status
- Update
- Public Device Record Key
- 002375fd-20fb-47ca-b7b5-14880ce12b29
Device Description
Med Cap, ENFit, Low Dose
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64469 | ENFit/non-ISO80369-standardized 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 connection which is not designed according to ISO 80369 at the other end (typically barbed, conical, ENLock, threaded or non-Luer-slip), intended to connect an enteral device (e.g., enteral syringe, feeding tube, administration set) with an ENFit connection typically with tubing or syringe; it does not connect a vial/bottle (i.e., not a vial/bottle adaptor). 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 | 20020451101457 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 00020451101453 | GS1 | ||||
| Unit of Use | 40020451101451 | GS1 |
Customer Contacts
- Phone
- 1-800-435-8316
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K894206 | 000 |