FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AMSure® SPIKE SET with SAFETY CONNECTOR
DI: 10704411005377
·
Model: 1
·
AMSINO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AMSure® SPIKE SET with SAFETY CONNECTOR
- Primary DI
- 10704411005377
- Version / Model
- 1
- Catalog Number
- E-1004
- Company Name
- AMSINO INTERNATIONAL, INC.
- Labeler DUNS
- 825673239
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 060a8d22-c662-4f51-8404-5dbcddc1ad2e
- Distribution End Date
- 2017-07-03
Device Description
AMSure® SPIKE SET with SAFETY CONNECTOR Clean, ready to use
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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 | 40704411005378 | GS1 | Case | 30 | Not in Commercial Distribution | 2017-07-03 |
| Primary | 10704411005377 | GS1 |