FDA UDI
In Commercial Distribution
🇺🇸 United States
Halyard
DI: 20680651493570
·
Model: 49357
·
O&M HALYARD, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
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Basic Information
- Brand Name
- Halyard
- Primary DI
- 20680651493570
- Version / Model
- 49357
- Catalog Number
- 49357
- Company Name
- O&M HALYARD, INC.
- Labeler DUNS
- 081057389
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2025-09-19
- Public Version
- 1
- Public Version Date
- 2025-09-29
- Public Version Status
- New
- Public Device Record Key
- 5bce4028-076d-4208-8625-9f1236ca20a1
Device Description
HALYARD* C-Section Fluid Collection Drape II, with Fenestrated Incise - Handi-Bin
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PUI | Drape, surgical, exempt | 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 | 30680651493577 | GS1 | CS | 30 | In Commercial Distribution | |
| Primary | 20680651493570 | GS1 | ||||
| Unit of Use | 90680651493579 | GS1 |
Customer Contacts
- Phone
- +1(844)425-9273
- [email protected]