FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Enteral Feeding
DI: 00020451101262
·
Model: 7772
·
MEDELA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
500
Basic Information
- Brand Name
- Enteral Feeding
- Primary DI
- 00020451101262
- Version / Model
- 7772
- Company Name
- MEDELA, INC.
- Labeler DUNS
- 052002029
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 4
- Public Version Date
- 2018-08-16
- Public Version Status
- Update
- Public Device Record Key
- 7a64647a-17eb-40bc-b32f-074e46f8a00e
- Distribution End Date
- 2018-08-14
Device Description
INTOPO Convert to Oral Syringe, Bulk, Non-Sterile
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
- No
- 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 |
|---|---|---|---|---|
| 61182 | Enteral feeding/medication connector, non-sterile | A non-sterile adaptor intended to enable connection of components of an enteral feeding and/or enteral medication administration kit (e.g., connection between tubing and syringe). It is typically a small plastic device containing a lumen to facilitate enteral administration after connection; it has no additional functionality and is dedicated to enteral administration applications. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00020451101262 | GS1 | ||||
| Unit of Use | 40020451101260 | GS1 | ||||
| Package | 10020451101269 | GS1 | 1 | Not in Commercial Distribution | 2018-08-14 |
Customer Contacts
- Phone
- (888)633-3528
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K894206 | 000 |