FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MABIS DMI
DI: 10767056075136
·
Model: D 7513
·
D-M-S HOLDINGS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MABIS DMI
- Primary DI
- 10767056075136
- Version / Model
- D 7513
- Catalog Number
- D 7513
- Company Name
- D-M-S HOLDINGS, INC.
- Labeler DUNS
- 062028220
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 5
- Public Version Date
- 2023-05-08
- Public Version Status
- Update
- Public Device Record Key
- dffb9dd8-d04f-41c9-8b27-3d40a66b512a
- Distribution End Date
- 2023-05-05
Device Description
U-BAG 24HR STERILE STANDARD ADHESIVE PEDIATRIC
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
- 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 |
|---|---|---|---|---|
| FOC | Bag, Urine Collection, Newborn | Gastroenterology, Urology | 876.5250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58929 | Adhesive paediatric urine collection bag, open-ended | A flexible plastic pouch with an adhesive flange (typically with a gender-specific shape) intended to be attached to the skin around the genitalia to collect urine from an infant/pre-adolescent paediatric patient. It is designed with an opening for urine drainage and is typically used for urine output measurement. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10767056075136 | GS1 |