FDA UDI
In Commercial Distribution
🇺🇸 United States
Demand Valve Resuscitator kit
DI: 07540195020078
·
Model: 01DV2015
·
O-Two Medical Technologies Inc
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Demand Valve Resuscitator kit
- Primary DI
- 07540195020078
- Version / Model
- 01DV2015
- Catalog Number
- 01DV2015
- Company Name
- O-Two Medical Technologies Inc
- Labeler DUNS
- 206449154
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-26
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 8ab3b184-a1bb-4191-8df2-d2c0d7afa7da
Device Description
O-Two Demand Valve Resuscitator Kit contains a Demand Valve resuscitator and a pressure regulator in carrying case. O-Two Demand Valve Resuscitator comes standard with pressure relief system and audible alarm as well a manual ventilation button conveniently located on the front of the resuscitator. The manual ventilation flow rate is fixed at 40 L/min. During spontaneous respirations, the Demand valve resuscitator is designed to provide 100% oxygen to the patient with minimal inspiratory effort. The oxygen demand flow is controlled by the patient’s inspiratory effort with a minimum peak flow rate of 140 L/min to accommodate the patient’s own respiratory distress situation.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17169 | Demand valve | A non-sterile device that is used to regulate the therapeutic gas flow to a patient in response to the patient's breathing effort. It is used, e.g., in ventilator breathing circuits, resuscitation devices and in on demand analgesia devices. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540195020078 | GS1 |
Customer Contacts
- Phone
- 1-800-387-3405
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 60 Degrees Celsius