FDA UDI
In Commercial Distribution
🇺🇸 United States
Enteral Feeding
DI: 00020451332123
·
Model: TLCAP
·
MEDELA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- Enteral Feeding
- Primary DI
- 00020451332123
- Version / Model
- TLCAP
- Company Name
- MEDELA, INC.
- Labeler DUNS
- 052002029
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2018-02-22
- Public Version
- 4
- Public Version Date
- 2023-10-05
- Public Version Status
- Update
- Public Device Record Key
- ad29d73b-5e53-47a5-87d2-a80c92fb1487
Device Description
Male TwistLok Non-Vented Cap, 10 units/package
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
- No
- 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 |
|---|---|---|---|---|
| 65823 | Non-ISO80369-3-standardized oral syringe | A manual device consisting of a calibrated hollow barrel (cylinder) and a moveable plunger intended for the administration of oral medication. The tip is not formatted according to the standard for small-bore connectors for enteral applications (ISO 80369-3) [I.e., not ENFit], however the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20020451332127 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 00020451332123 | GS1 | ||||
| Unit of Use | 40020451332121 | GS1 |
Customer Contacts
- Phone
- 1-800-435-8316
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092986 | 000 |