FDA UDI
In Commercial Distribution
🇺🇸 United States
Patient Drape/ Clear View Drape
DI: 00848340010491
·
Model: O-CVD-A1
·
ADVANCE MEDICAL DESIGNS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Patient Drape/ Clear View Drape
- Primary DI
- 00848340010491
- Version / Model
- O-CVD-A1
- Company Name
- ADVANCE MEDICAL DESIGNS, INC.
- Labeler DUNS
- 130785884
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-09
- Public Version
- 1
- Public Version Date
- 2022-05-17
- Public Version Status
- New
- Public Device Record Key
- 3437d175-f247-4b03-a5d5-bbf5362ae8d3
Device Description
Disposable Waste Fluid Collection Device
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 47783 | Patient surgical drape, single-use | A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10848340010498 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00848340010491 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K003670 | 000 |