FDA UDI
In Commercial Distribution
🇺🇸 United States
Adult Lopez Valve®
DI: 00801741052361
·
Model: 0056000
·
C. R. Bard, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Adult Lopez Valve®
- Primary DI
- 00801741052361
- Version / Model
- 0056000
- Catalog Number
- 0056000
- Company Name
- C. R. Bard, Inc.
- Labeler DUNS
- 016898496
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-06
- Public Version
- 4
- Public Version Date
- 2023-08-14
- Public Version Status
- Update
- Public Device Record Key
- c23077f9-304d-4237-acc7-b026c5947eb5
Device Description
Adult Lopez Valve®
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
- No
- 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 |
|---|---|---|---|---|
| 60538 | Luer/Luer linear connector, single-use | A small, non-powered, noninvasive tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741052368 | GS1 | CA | 50 | In Commercial Distribution | |
| Primary | 00801741052361 | GS1 |
Customer Contacts
- Phone
- +1(800)526-4455
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K915171 | 000 |