FDA UDI
In Commercial Distribution
🇺🇸 United States
Elite CPR Face Shield
DI: 00816703023112
·
Model: ELITE-21105
·
MEDSOURCE INTERNATIONAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Elite CPR Face Shield
- Primary DI
- 00816703023112
- Version / Model
- ELITE-21105
- Catalog Number
- Not Applicable
- Company Name
- MEDSOURCE INTERNATIONAL LLC
- Labeler DUNS
- 041674552
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-20
- Public Version
- 2
- Public Version Date
- 2022-11-29
- Public Version Status
- Update
- Public Device Record Key
- 219eb139-bac7-4d73-9321-98e9a93214eb
Device Description
CPR Face Shield / Elite First Aid Part Number: 605
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
- 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
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 63222 | Cardiopulmonary resuscitation mouthpiece/cover | A non-sterile device that consists of a mouthpiece with an integrated face/body covering sheet intended to be placed over a patient during cardiopulmonary resuscitation (CPR) to prevent cross-contamination between patient and CPR administrator; it may also include directions/positional markers printed on the cover intended to assist the administrator during CPR. The mouthpiece is designed to be used as a barrier during resuscitation (i.e., “mouth-to-mouthpiece”) as an alternative to conventional “mouth-to-mouth”. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00816703023129 | GS1 | Case | 400 | In Commercial Distribution | |
| Primary | 00816703023112 | GS1 |