Identity
- Trade Name
- EASY GRIP FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, reusable FDA UDI
- Device Name
- This Bag Valve Mask Resuscitator kit contains an Adult EASY GRIP® PVC Bag Valve Mask Resuscitator, three different sizes Guedel Airways and two different sizes Face masks for adult patients. The Adult EASY GRIP® PVC Bag Valve Mask Resuscitator is a reusable device for manual ventilation. It is designed for use in various clinical settings to provide respiratory support to the respiratory distressed or non-breathing ADULT patient. When used with a supplemental oxygen supply, the device may provide 100% oxygen on every squeeze of the bag. The Resuscitator comes with a Pressure Relief Valve set at 70 cm H2O, which can be overridden by the operator if desired. FDA UDI
- Model / Reference
- 01BM2000-M FDA UDI
- Description
- This Bag Valve Mask Resuscitator kit contains an Adult EASY GRIP® PVC Bag Valve Mask Resuscitator, three different sizes Guedel Airways and two different sizes Face masks for adult patients. The Adult EASY GRIP® PVC Bag Valve Mask Resuscitator is a reusable device for manual ventilation. It is designed for use in various clinical settings to provide respiratory support to the respiratory distressed or non-breathing ADULT patient. When used with a supplemental oxygen supply, the device may provide 100% oxygen on every squeeze of the bag. The Resuscitator comes with a Pressure Relief Valve set at 70 cm H2O, which can be overridden by the operator if desired. FDA UDI
Identifiers
- Catalog Number
- 01BM2000-M FDA UDI
- Primary DI / UDI-DI
- 07540195000391 FDA UDI
- FDA Product Code
- BTM FDA UDI
- GMDN Term
- Pulmonary resuscitator, manual, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5915 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulmonary resuscitator, manual, reusable
Easy Grip by O-Two Medical Technologies Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary resuscitator, manual, reusable.
- Med-Tech Resource — MED-TECH RESOURCE, LLC · Class II
- MedSource Resuscitator, Infant (BVM), 10/case — MEDSOURCE INTERNATIONAL LLC · Class II
- CPR Bag Reusable — MERCURY ENTERPRISES, INC. · Class II
- Hudson RCI — TELEFLEX INCORPORATED · Class II
- Life Support Products — Allied Medical LLC · Class II
- LIFESAVER — GaleMed Xiamen Co., Ltd. · Class II
- Life Support Products (LSP) — Allied Medical LLC · Class II
- NeoNatalie Resuscitator (US) — Laerdal Medical Corp. · Class II
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
- O-Two Medical Technologies Inc
Sources (1)
- FDA UDI a3882865-3c16-4cd2-a2a7-e39f493a5c06 36 fields · synced May 30, 2026