Identity
- Trade Name
- Emergency Rescue Mask FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, single-use FDA UDI
- Device Name
- It is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere. FDA UDI
- Model / Reference
- ERM101 FDA UDI
- Description
- It is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B859ERM1010 FDA UDI
- 510(k) Number
- K083418 FDA UDI
- FDA Product Code
- CBP FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation mask, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5870 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiopulmonary resuscitation mask, single-use
Emergency Rescue Mask by Cbx Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary resuscitation mask, single-use.
- 16PW - Class A Burn Relief — Certified Safety Manufacturing, Inc. · Class I
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- First Aid Only — Acme United Corporation · Class I
- 10PW - Oklahoma Gas & Electric - Poly White — Certified Safety Manufacturing, Inc. · N
- MedSource Emergency Pocket Care Mask, w/o O2 port, Hard Case — MEDSOURCE INTERNATIONAL LLC · Class II
- Rescue Breather — O-Two Medical Technologies Inc · Class I
- EMT - Duke Energy TD - Red Bag — Certified Safety Manufacturing, Inc. · Class II
- ZLB - 10 - Metra 49-980170 — Certified Safety Manufacturing, Inc. · Class II
Cleared under the same submission
K083418 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cbx Llc
Sources (1)
- FDA UDI 67b4cc64-3e03-4c5d-b864-5e7787fcc1d7 34 fields · synced Jun 8, 2026