FDA UDI
In Commercial Distribution
🇺🇸 United States
AMShield® Disinfecting Cap
DI: 30704411011877
·
Model: 1
·
AMSINO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
200
Basic Information
- Brand Name
- AMShield® Disinfecting Cap
- Primary DI
- 30704411011877
- Version / Model
- 1
- Catalog Number
- DCF2000
- Company Name
- AMSINO INTERNATIONAL, INC.
- Labeler DUNS
- 825673239
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2020-03-20
- Public Version
- 3
- Public Version Date
- 2020-09-09
- Public Version Status
- Update
- Public Device Record Key
- 6d0b39b1-b650-49b1-81d6-d4ba13a19465
Device Description
AMShield® Disinfecting Cap Contains 70% IPA for Needle-Free Valves 200 PCS Individually Packed
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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LKB | Pad, Alcohol, Device Disinfectant | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61141 | Luer-formatted disinfection cap | A small, noninvasive, closed-ended Luer attachment intended to be attached to a connector in an intravenous line (e.g., needleless valve, Luer access valve, male Luer connector) to disinfect the valve surface and/or maintain disinfection, and for protection. It is a synthetic polymer cap containing a foam material saturated with isopropyl alcohol (IPA) as the disinfectant; it may contain other components. The cap may be removed shortly after disinfection, or remain in place to maintain disinfection for a limited period. This device may be supplied with male Luer end caps (not containing disinfectant) for use on the disconnected IV tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40704411011874 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 30704411011877 | GS1 | ||||
| Unit of Use | 00704411011876 | GS1 |