FDA UDI
In Commercial Distribution
🇺🇸 United States
SureStep™ Foley System Lubri-Sil® I.C. Complete Care® Temp Sensing Catheter Tray
DI: 00801741099717
·
Model: B319516AM
·
C. R. Bard, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SureStep™ Foley System Lubri-Sil® I.C. Complete Care® Temp Sensing Catheter Tray
- Primary DI
- 00801741099717
- Version / Model
- B319516AM
- Catalog Number
- B319516AM
- Company Name
- C. R. Bard, Inc.
- Labeler DUNS
- 016898496
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-27
- Public Version
- 3
- Public Version Date
- 2020-12-04
- Public Version Status
- Update
- Public Device Record Key
- 9c6711ab-95c6-4a23-bbc2-99912e790b04
Device Description
SureStep™ Foley Tray System Lubri-Sil® I.C. Complete Care® Temperature Sensing Foley Catheter Tray
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
- MR Conditional
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MJC | CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES | Gastroenterology, Urology | 876.5130 | 2 |
| EZL | CATHETER, RETENTION TYPE, BALLOON | Gastroenterology, Urology | 876.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32031 | Indwelling urethral catheterization kit, adult | A collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741099714 | GS1 | CA | 10 | In Commercial Distribution | |
| Primary | 00801741099717 | GS1 |
Customer Contacts
- Phone
- +1(800)526-4455
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 16 | French |