FDA UDI
In Commercial Distribution
🇺🇸 United States
Urological Drainage Bag
DI: 00848340020346
·
Model: CC166NS
·
ADVANCE MEDICAL DESIGNS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Urological Drainage Bag
- Primary DI
- 00848340020346
- Version / Model
- CC166NS
- Company Name
- ADVANCE MEDICAL DESIGNS, INC.
- Labeler DUNS
- 130785884
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-18
- Public Version
- 1
- Public Version Date
- 2024-03-26
- Public Version Status
- New
- Public Device Record Key
- f99b8a60-4ce7-47fb-82c4-51ba82bf4f3f
Device Description
Urologic Drain Bag
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KKX | Drape, surgical | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58848 | Extracorporeal circuit waste bag | A flexible container intended to be used for the collection of waste fluids during preparation and processing of an extracorporeal circuit (e.g., autotransfusion, haemodialysis, haemofiltration, apheresis, adsorption treatment), including the collection and rinsing of ultrafiltrate fluid which may contain blood components. The device typically consists of a plastic pouch with a piece of short tubing and a connector (e.g., Luer-lock) intended to be connected to the tubing system of the extracorporeal circuit and possibly an outlet tap. The contents are considered potentially contaminated and should be disposed of according to local requirements. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10848340020343 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00848340020346 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K012168 | 000 |