FDA UDI
In Commercial Distribution
🇺🇸 United States
Medichoice
DI: 10885632101083
·
Model: UCT870
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medichoice
- Primary DI
- 10885632101083
- Version / Model
- UCT870
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-20
- Public Version
- 3
- Public Version Date
- 2020-12-04
- Public Version Status
- Update
- Public Device Record Key
- 9ec0b425-61ef-4e2c-9dc5-83a5e5c10285
Device Description
Tray Catheterization Urethral With 14Fr Plastic Catheter 1000 Milliliter Outer Basin Tray 1 Pair Vinyl Gloves 1 Waterproof Drape 1 Fenestrated Drape 1 3GR Pack Lubricating Jelly 3 Pvp Swab Sticks Not Made With Natural Rubber Latex Sterile MediChoice
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|---|---|
| Package | 50885632101081 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 10885632101083 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius