FDA UDI
In Commercial Distribution
🇺🇸 United States
ASP MEDICAL
DI: 00840216105010
·
Model: UDT401
·
Asp Global, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ASP MEDICAL
- Primary DI
- 00840216105010
- Version / Model
- UDT401
- Company Name
- Asp Global, LLC
- Labeler DUNS
- 080361159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-29
- Public Version
- 1
- Public Version Date
- 2022-08-08
- Public Version Status
- New
- Public Device Record Key
- bc278e43-367d-4d11-85bb-22956398be31
Device Description
UMBILICAL CORD CLAMP, 1/EA,100/BX, 500/CS (5BX/CS)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00840216105010 | GS1 |