FDA UDI
In Commercial Distribution
🇺🇸 United States
NURSE ASSIST
DI: B15072024
·
Model: 7202
·
NURSE ASSIST, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
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Basic Information
- Brand Name
- NURSE ASSIST
- Primary DI
- B15072024
- Version / Model
- 7202
- Company Name
- NURSE ASSIST, INC.
- Labeler DUNS
- 869434464
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2020-12-04
- Public Version Status
- Update
- Public Device Record Key
- 90337208-48da-4d08-8986-3febae18ec5e
Device Description
14 FR RED RUBBER CATHETER-FORCEPS PROCEDURE
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 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 |
|---|---|---|---|---|---|---|
| Primary | B15072024 | HIBCC | ||||
| Unit of Use | B15072020 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K904158 | 000 |