FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDLINE
DI: 10080196493401
·
Model: DYNJ04220
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MEDLINE
- Primary DI
- 10080196493401
- Version / Model
- DYNJ04220
- Catalog Number
- DYNJ04220
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-18
- Public Version
- 1
- Public Version Date
- 2020-05-26
- Public Version Status
- New
- Public Device Record Key
- 12942d9e-8f7d-4770-9dcb-f467c1094441
Device Description
CLAMP UMBILICAL CORD, PLASTIC
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
- Yes
- 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 |
|---|---|---|---|---|
| HFW | Clamp, umbilical | Obstetrics/Gynecology | 884.4530 | 2 |
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 | 40080196493402 | GS1 | CASE | 100 | In Commercial Distribution | |
| Primary | 10080196493401 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]