FDA UDI
In Commercial Distribution
🇺🇸 United States
MediChoice
DI: 10885632102097
·
Model: SLB0019
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MediChoice
- Primary DI
- 10885632102097
- Version / Model
- SLB0019
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-31
- Public Version
- 2
- Public Version Date
- 2021-01-08
- Public Version Status
- Update
- Public Device Record Key
- c330a41e-963a-49d2-b203-ee258a02f5ff
Device Description
Bag Leg With Flip Valve 23 Inch Leg Strap, Button Hook Medium Capacity, Not Made With Natural Rubber Latex Vinyl 19 Oz (600ml) MediChoice
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
- 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 |
|---|---|---|---|---|
| FAQ | BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE | Gastroenterology, Urology | 876.5250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58921 | Non-wearable adult urine collection bag, open-ended | A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885632102095 | GS1 | 48 | In Commercial Distribution | ||
| Primary | 10885632102097 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid freezing and excessive heat