Demand Valve Resuscitator kit

Primary DI
07540195020092
Brand
Demand Valve Resuscitator kit
Company
O-Two Medical Technologies Inc
Model
01DV2025
Catalog number
01DV2025
Device description
O-Two Demand Valve Resuscitator Kit contains a Demand Valve resuscitator, a pressure regulator and an aspirator in carrying case. O-Two Demand Valve R
Published
2015-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07540195020092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07540195020092075401950200927540195020092

GMDN Terms

TermDefinition
Demand valveA 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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
206449154
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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