FDA UDI
In Commercial Distribution
🇺🇸 United States
AMSure® Enteral Irrigation Kit with Bulb Syringe
DI: 10704411008484
·
Model: 1
·
AMSINO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AMSure® Enteral Irrigation Kit with Bulb Syringe
- Primary DI
- 10704411008484
- Version / Model
- 1
- Catalog Number
- AS121
- Company Name
- AMSINO INTERNATIONAL, INC.
- Labeler DUNS
- 825673239
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-05
- Public Version
- 1
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- 40c107ef-01f3-4630-ae32-71b665fba237
Device Description
AMSure® Enteral Irrigation Kit with Bulb Syringe Clean, Ready to Use CONTENTS: • 1 Graduated Container, 500 ml • 1 Bulb Irrigation Syringe, 60 ml • 1 Small Tube Adapter • 1 Patient ID Label
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
- 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 |
|---|---|---|---|---|---|---|
| Package | 40704411008485 | GS1 | case | 30 | In Commercial Distribution | |
| Primary | 10704411008484 | GS1 |