FDA.report

NITRONOX PLUS

Primary DI
00816711020684
Brand
NITRONOX PLUS
Company
PARKER-HANNIFIN CORPORATION
Model
NOX-PLUS-070
Device description
NITRONOX PLUS DEMAND FLOW NITROUS OXIDE AND OXYGEN FLOWMETER, 0-70%
Published
2021-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
BZRMixer, Breathing Gases, Anesthesia Inhalation

Product Code Classifications

CodeDeviceSpecialtyClass
BZRMixer, Breathing Gases, Anesthesia InhalationAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816711020684PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816711020684008167110206848167110206840816711020684

GMDN Terms

TermDefinition
Inhalational analgesia unitA device primarily designed to administer analgesic gases to the patient, or produce analgesic vapours for inhalation. The unit will typically include a demand valve; some may be connected to a vaporizer calibrated for the administration of analgesic concentrations of inhalational anaesthetic agents. Typically used: 1) during labour to help the patient retain her consciousness while pain sensations are subdued; or 2) in dentistry.

Sterilization Methods

Method

Regulatory Flags

DUNS number
004175550
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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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