FDA UDI
In Commercial Distribution
🇺🇸 United States
AMSure® Umbilical Cord Clamp
DI: 10704411008095
·
Model: 1
·
AMSINO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- AMSure® Umbilical Cord Clamp
- Primary DI
- 10704411008095
- Version / Model
- 1
- Catalog Number
- UCC100
- Company Name
- AMSINO INTERNATIONAL, INC.
- Labeler DUNS
- 825673239
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-04
- Public Version
- 1
- Public Version Date
- 2018-07-05
- Public Version Status
- New
- Public Device Record Key
- 1bd5791f-db76-4a2a-be36-aa1eeaba1aa9
Device Description
AMSure® Umbilical Cord Clamp
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
- Yes
- 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 |
|---|---|---|---|---|
| FOD | Device, Occlusion, Umbilical | General Hospital | 880.5950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43998 | Umbilical cord clamp, single-use | A sterile, hand-held manual surgical instrument designed to temporarily compress the umbilical cord immediately after birth. It is used before cutting or ligating (e.g., with a clip) the cord, and is intended to enable aseptic haemostasis. It is typically made of plastic material and may incorporate features such as serrations on the contact area and/or a security lock. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50704411008093 | GS1 | master carton | 20 | In Commercial Distribution | |
| Package | 40704411008096 | GS1 | case | 50 | In Commercial Distribution | |
| Primary | 10704411008095 | GS1 |