FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AMSure ® Enteral Administration Kit
DI: 10704411016168
·
Model: 1
·
AMSINO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AMSure ® Enteral Administration Kit
- Primary DI
- 10704411016168
- Version / Model
- 1
- Catalog Number
- ENF1200K2
- Company Name
- AMSINO INTERNATIONAL, INC.
- Labeler DUNS
- 825673239
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-24
- Public Version
- 1
- Public Version Date
- 2023-06-01
- Public Version Status
- New
- Public Device Record Key
- abff0c34-ab15-4ebd-9912-674d06a4b6b5
- Distribution End Date
- 2023-05-24
Device Description
Enteral Administration Kit FOR USE WITH AMSure® ENTERAL FEEDING PUMP CONTENTS:Enteral Feeding 1200 mL Bag Pump Set with ENFit Connector ENFit Transition Connector
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64461 | Enteral feeding noninvasive-component set | A collection of devices such as tubing, connectors, chambers, clamps, and bags/bottles intended to be used to create the noninvasive (i.e., fully external) portion of an enteral feeding device assembly; it is not intended for intravenous (IV) administration. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40704411016169 | GS1 | case | 30 | Not in Commercial Distribution | 2023-05-17 |
| Primary | 10704411016168 | GS1 |