FDA UDI
In Commercial Distribution
🇺🇸 United States
MediChoice
DI: 10885632102103
·
Model: SLB0019T
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MediChoice
- Primary DI
- 10885632102103
- Version / Model
- SLB0019T
- 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
- 684958a8-e331-4e94-8bab-cf4219a682f2
Device Description
Bag Leg With Flip Valve 18 Inch Extension Tubing Button Hook 23 Inch Leg Strap Medium 600 Milliliter Vinyl Not Made With Natural Rubber Latex Sterile 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 | 50885632102101 | GS1 | 48 | In Commercial Distribution | ||
| Primary | 10885632102103 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid freezing and excessive heat
- Type
- Special Storage Condition, Specify
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius