FDA UDI
In Commercial Distribution
🇺🇸 United States
Infinity Enteral Feeding Pump
DI: 10814844000686
·
Model: INFKIT1
·
ZEVEX INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Infinity Enteral Feeding Pump
- Primary DI
- 10814844000686
- Version / Model
- INFKIT1
- Company Name
- ZEVEX INTERNATIONAL, INC.
- Labeler DUNS
- 612746933
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-03
- Public Version
- 1
- Public Version Date
- 2021-11-11
- Public Version Status
- New
- Public Device Record Key
- 5a29fdac-fab9-4bb7-9b6b-f7968cf686f1
Device Characteristics
- Single Use
- No
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| LZH | Pump, Infusion, Enteral | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13209 | Enteral feeding pump | A mains electricity (AC-powered) device designed to create pressure to accurately control the rates of flow of nutrient fluids directly into the stomach, duodenum, or jejunum, via enteral tubing, in patients who are unable or unwilling to consume adequate nutrients. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10814844000686 | GS1 |
Customer Contacts
- Phone
- 800-970-2337
- [email protected]