FDA UDI
In Commercial Distribution
🇺🇸 United States
Enteral Delivery Gravity Bag Set
DI: 00616784428031
·
Model: 4280
·
DYNAREX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
Basic Information
- Brand Name
- Enteral Delivery Gravity Bag Set
- Primary DI
- 00616784428031
- Version / Model
- 4280
- Company Name
- DYNAREX CORPORATION
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- e0523f9a-b782-4542-be82-11ffd2ea6c54
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60445 | Enteral feeding kit, adult/paediatric, non-sterile | A collection of non-sterile devices that includes tubing and other materials intended to administer nutrient liquids directly into the stomach, duodenum, or jejunum of an adult or paediatric (excludes infants) patient by means of gravity or an enteral pump. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00616784428031 | GS1 | ||||
| Unit of Use | 00616784428024 | GS1 |