FDA UDI
In Commercial Distribution
🇺🇸 United States
AeroShield CPR Face Shield
DI: 09341394027183
·
Model: AFS001US
·
AERO HEALTHCARE (US), LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AeroShield CPR Face Shield
- Primary DI
- 09341394027183
- Version / Model
- AFS001US
- Catalog Number
- AFS001US
- Company Name
- AERO HEALTHCARE (US), LLC
- Labeler DUNS
- 008186174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-02
- Public Version
- 1
- Public Version Date
- 2026-04-10
- Public Version Status
- New
- Public Device Record Key
- 40998e8b-36fc-4cf1-988b-87153c903a35
Device Description
CPR Face Shield
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
- No
- 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 |
|---|---|---|---|---|
| KGB | Mask, Oxygen, Non-Rebreathing | Anesthesiology | 868.5570 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61326 | Cardiopulmonary resuscitation mask, single-use | 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) or as part of first aid kits. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09341394027183 | GS1 |