FDA.reportPublic FDA data

NITRONOX PLUS

Primary DI
00816711020714
Brand
NITRONOX PLUS
Company
PARKER-HANNIFIN CORPORATION
Model
NOX-PLUS-5050
Device description
NITRONOX PLUS DEMAND FLOW NITROUS OXIDE AND OXYGEN FLOWMETER, 50/50
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

Product Codes#

Code, Name table
CodeName
BZRMixer, Breathing Gases, Anesthesia Inhalation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZRMixer, Breathing Gases, Anesthesia InhalationAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816711020714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816711020714008167110207148167110207140816711020714

GMDN Terms#

Term, Definition table
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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816711024972MATRX SCAV(WO/HOOD)WO/SHUTOFF91515197915151972026-02-23
00816711020097ANALGESIA GAS MIXER, DIGITAL MDM DELIVERY SYSTEM40151601 KOR2025-09-24
00816711020424NITRONOX SCAVENGERNOX-53002025-09-24
00816711024958PORTER,MED BR CIR,6FT,20PCKDMC-12-6DMC-12-62025-09-17
00816711024965PORTER,MED BR CIR,10FT,20PCKDMC-12-10DMC-12-102025-09-17
00816711024941HOSE N2O DISS/DISS 8 FT850885082025-02-27
00816711024224SCAVENGER, EAVS, MIDASEAVS-5000EAVS-50002025-02-21
00816711024927DEMAND VALVE, POS PR., DISS1506-1D1506-1D2025-02-21
00816711024934HA,O2,INTL (DISSF X DISSF)2FT92305297-2 92305297-2 2025-02-21
00816711024231MIDAS, REMOTE, 70%-W-O2 AUS615161512024-10-14
00816711024248MIDAS, REMOTE, 70%-W-N20 AUS618161812024-10-14
00816711024255MIDAS, REMOTE, 60%-W-O2, SWE614261422024-10-14
00816711024262MIDAS, REMOTE, 60%-W-N2O SWE617261722024-10-14
00816711024279MIDAS, REMOTE, 50%-W-O2613061302024-10-14
00816711024286MIDAS, REMOTE, 60%-W-O2614061402024-10-14
00816711024293MIDAS, REMOTE, 70%-W-O2615061502024-10-14
00816711024309MIDAS, REMOTE, 50%-W-N2O616061602024-10-14
00816711024316MIDAS, REMOTE, 60%-W-N2O617061702024-10-14
00816711024323MIDAS, REMOTE, 70%-W-N20 618061802024-10-14
00816711024330MIDAS, PORTABLE, 70%-W-O2 AUS605160512024-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20889483528751AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483528867AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483528942AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483568795AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483542801AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483542849AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483542863AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483542887AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483542924AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483542962AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483222154AmbuSUNMED, LLCBZR2025-12-19
20889483222161AmbuSUNMED, LLCBZR2025-12-19
20889483222185AmbuSUNMED, LLCBZR2025-12-19
20889483222192AmbuSUNMED, LLCBZR2025-12-19
20889483222208AmbuSUNMED, LLCBZR2025-12-19
20889483222222AmbuSUNMED, LLCBZR2025-12-19
20889483222239AmbuSUNMED, LLCBZR2025-12-19
20889483231491AmbuSUNMED, LLCBZR2025-12-19
20889483231521AmbuSUNMED, LLCBZR2025-12-19
20889483231538AmbuSUNMED, LLCBZR2025-12-19
20889483231583AmbuSUNMED, LLCBZR2025-12-19
20889483231613AmbuSUNMED, LLCBZR2025-12-19
20889483229894Disposable Medical Hyperinflation SystemSUNMED, LLCBZR2025-11-10
20889483231682Disposable Medical Hyperinflation SystemSUNMED, LLCBZR2025-11-10
00816711024231MIDAS, REMOTE, 70%-W-O2 AUSPARKER-HANNIFIN CORPORATIONBZR2024-10-14
00816711024248MIDAS, REMOTE, 70%-W-N20 AUSPARKER-HANNIFIN CORPORATIONBZR2024-10-14
00816711024255MIDAS, REMOTE, 60%-W-O2, SWEPARKER-HANNIFIN CORPORATIONBZR2024-10-14
00816711024262MIDAS, REMOTE, 60%-W-N2O SWEPARKER-HANNIFIN CORPORATIONBZR2024-10-14