FDA UDI
In Commercial Distribution
🇺🇸 United States
SureStep™ Foley Tray System Add-A-Foley Catheter
DI: 00801741100352
·
Model: A304400
·
C. R. Bard, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SureStep™ Foley Tray System Add-A-Foley Catheter
- Primary DI
- 00801741100352
- Version / Model
- A304400
- Catalog Number
- A304400
- Company Name
- C. R. Bard, Inc.
- Labeler DUNS
- 016898496
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-12-08
- Public Version
- 4
- Public Version Date
- 2020-12-04
- Public Version Status
- Update
- Public Device Record Key
- 944d7efd-e4dd-450c-85f9-8f9ed4552775
Device Description
SureStep® Foley Tray System Add-A-Foley Catheter 350 ml Urine Meter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| 61355 | Urethral catheterization support kit, urinary drainage | A collection of non-surgically invasive devices intended to assist a healthcare professional to insert a urethral catheter (not included) into the urinary bladder, typically for drainage of urine; some types may also be intended for catheter removal. It typically includes forceps, dressings, gloves, and drapes; it does not include pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741100359 | GS1 | CA | 10 | In Commercial Distribution | |
| Primary | 00801741100352 | GS1 |
Customer Contacts
- Phone
- +1(800)526-4455
- [email protected]