FDA UDI
In Commercial Distribution
🇺🇸 United States
Facemask with one way valve in hard shell carrying case
DI: B002000CC0
·
Model: 2025
·
B.L.S. Systems Limited
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Facemask with one way valve in hard shell carrying case
- Primary DI
- B002000CC0
- Version / Model
- 2025
- Catalog Number
- 2025
- Company Name
- B.L.S. Systems Limited
- Labeler DUNS
- 200103823
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-13
- Public Version
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- a26e2962-1011-46dc-80b7-43ad68eb5b0a
Device Description
Rescuer disposable CPR mask with one way valve in hard shell carrying case
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| CBP | Valve, Non-Rebreathing | Anesthesiology | 868.5870 | 2 |
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 | B002000CC0 | HIBCC | ||||
| Package | B0022000CC8 | HIBCC | Case of 100 | 100 | In Commercial Distribution |
Customer Contacts
- Phone
- 905 339 1069
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K010191 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 60 Degrees Celsius