FDA UDI
In Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 20192253064374
·
Model: H1SHIELD50
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 20192253064374
- Version / Model
- H1SHIELD50
- Catalog Number
- H1SHIELD50
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2024-02-08
- Public Version
- 1
- Public Version Date
- 2024-02-16
- Public Version Status
- New
- Public Device Record Key
- faa2b96e-c9c7-42e8-a262-ad2704ccf8ba
Device Description
SECUREGARD VISOR, ONE-PIECE, HALF-S
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| LYU | ACCESSORY, SURGICAL APPAREL | General, Plastic Surgery | 878.4040 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11961 | Face splash shield, single-use | A clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50192253064375 | GS1 | CASE | 2 | In Commercial Distribution | |
| Primary | 20192253064374 | GS1 | ||||
| Unit of Use | 10192253064377 | GS1 |