FDA UDI
In Commercial Distribution
🇺🇸 United States
Zorro-Flow Inc.
DI: 00850049673082
·
Model: ZF-F-S Assembly
·
ZORROFLOW LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Zorro-Flow Inc.
- Primary DI
- 00850049673082
- Version / Model
- ZF-F-S Assembly
- Catalog Number
- ZF-F-S
- Company Name
- ZORROFLOW LLC
- Labeler DUNS
- 111226728
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-01
- Public Version
- 1
- Public Version Date
- 2024-11-11
- Public Version Status
- New
- Public Device Record Key
- 6fef2ab0-8c97-4d9f-a26c-9c45cf9ec403
- Distribution End Date
- 2037-01-01
Device Description
Zorro-Flow Small Female Urine Collection System, Assembly of 1 unit
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
- Yes
- 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 |
|---|---|---|---|---|
| 58919 | Wearable adult urine collection bag, closed-ended | A flexible plastic pouch designed to connect to a urinary catheter and to be strapped to or worn on the leg of an adult/adolescent patient to collect discharged urine; it is not designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility and is disposed of when full. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850049673089 | GS1 | carton | 6 | In Commercial Distribution | 2037-01-01 |
| Primary | 00850049673082 | GS1 | ||||
| Package | 20850049673086 | GS1 | Box | 12 | In Commercial Distribution | 2037-01-01 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 6 | Kilogram |