FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Moore Medical CPR Mask, Barrier Dev. w/O2 73509
DI: 07045430044630
·
Model: 830046
·
Laerdal Medical AS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Moore Medical CPR Mask, Barrier Dev. w/O2 73509
- Primary DI
- 07045430044630
- Version / Model
- 830046
- Catalog Number
- 830046
- Company Name
- Laerdal Medical AS
- Labeler DUNS
- 730624095
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-20
- Public Version
- 4
- Public Version Date
- 2023-02-14
- Public Version Status
- Update
- Public Device Record Key
- 57834541-519d-4701-97c3-0e7dd0069d84
- Distribution End Date
- 2023-02-01
Device Description
The Moore Medical CPR Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult.
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| CBP | Valve, Non-Rebreathing | Anesthesiology | 868.5870 | 2 |
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 | 07045430044630 | GS1 | ||||
| Package | 07045432068450 | GS1 | Carton | 100 | Not in Commercial Distribution | 2023-02-01 |
Customer Contacts
- Phone
- (800)4311055
- [email protected]
- Phone
- (877) 523-7325
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 52 Degrees Celsius