FDA UDI
In Commercial Distribution
🇺🇸 United States
HEADSTAR
DI: 04711402231263
·
Model: HS-8800
·
HEADSTAR MEDICAL PRODUCTS CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HEADSTAR
- Primary DI
- 04711402231263
- Version / Model
- HS-8800
- Company Name
- HEADSTAR MEDICAL PRODUCTS CO., LTD.
- Labeler DUNS
- 658122049
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-27
- Public Version
- 1
- Public Version Date
- 2020-06-04
- Public Version Status
- New
- Public Device Record Key
- eebfa403-c769-48d0-bfbc-25afe6e53ec9
Device Description
Headstar 100% latex-free face masks come in a wide variety of sizes and materials to suit the patient's needs. #0 Silicone mask for small Infant Headstar offers anatomically designed face mask that brings maximum comfort to the patient.
Device Characteristics
- Single Use
- No
- 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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BYG | Mask, Oxygen | Anesthesiology | 868.5580 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36066 | Cardiopulmonary resuscitation mask, reusable | A flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04711402231263 | GS1 |