FDA UDI
In Commercial Distribution
🇺🇸 United States
Bard® Flip-Flo™ Catheter Valve
DI: 00801741131776
·
Model: BFF5
·
C. R. Bard, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Bard® Flip-Flo™ Catheter Valve
- Primary DI
- 00801741131776
- Version / Model
- BFF5
- Catalog Number
- BFF5
- Company Name
- C. R. Bard, Inc.
- Labeler DUNS
- 016898496
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-10
- Public Version
- 3
- Public Version Date
- 2022-05-10
- Public Version Status
- Update
- Public Device Record Key
- 1606bea7-ef6a-45ab-a02b-e9709ae8afd8
Device Description
Bard® Flip-Flo™ Catheter Valve
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| KNX | COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER | Gastroenterology, Urology | 876.5250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63257 | Urethral/suprapubic catheter valve-connector | A small, sterile valve intended to be connected to a urethral and/or suprapubic catheter to allow intermittent bladder drainage/filling (as an alternative to continuous drainage). As the bladder is intended to store urine between drainage it may be intended to help maintain bladder tone/capacity. It is typically a small plastic two-way connector with an integrated faucet (stopcock). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741131773 | GS1 | CA | 5 | In Commercial Distribution | |
| Primary | 00801741131776 | GS1 |
Customer Contacts
- Phone
- +1(800)526-4455
- [email protected]