FDA.reportPublic FDA data

NIFometer

Primary DI
10641043340011
Brand
NIFometer
Company
MERCURY ENTERPRISES, INC.
Model
10-34001
Published
2016-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BXRMeter, Airway Pressure (Inspiratory Force)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXRMeter, Airway Pressure (Inspiratory Force)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032593000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032593000MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETERMercury Medical2004-02-03BXR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30641043340015PackageGS110In Commercial Distribution
10641043340011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3064104334001530641043340015
1064104334001110641043340011

GMDN Terms#

Term, Definition table
TermDefinition
Airway pressure monitor, non-poweredA mechanical device designed to provide a visual indication of a patient's airway pressure during ventilation. It is typically contained in a clear housing marked with a pressure scale [e.g., 5 to 60 cm H20 (hPa)], and has a spring-loaded indicator that, in resistance to the expiratory flow of air, registers the airway pressure. It connects to the manometer port of a variety of ventilation devices such as a resuscitation bag, hyperinflation bag, continuous positive airway pressure (CPAP) mask, or a CPAP circuit. It may be used in a healthcare setting (including ambulatory) or in the home. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(727) 573-0088hospitalcustomerservice@mercurymed.com

Regulatory Flags#

DUNS number
032705659
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10641043508473Neo-Tee T-Piece Resuscitator10-508232026-03-26
10641043563311CPR-2 Bag10-563312026-02-12
10641043564608CPR-2 Bag10-564602025-12-16
30641043564602CPR-2 Bag10-564602025-12-16
10641043320006EZflow10-320002016-03-07
10641043320013EZflow10-320012016-03-07
10641043320020EZflow10-320022016-03-09
10641043320037EZflow MAX10-320032016-03-09
10641043320044EZflow MAX10-320042016-03-09
10641043320051EZflow10-320052016-03-09
10641043320068EZflow10-320062016-03-09
10641043320099EZflow MAX10-320092016-03-09
10641043588727Hyperinflation System10-588722025-09-11
10641043566039CPR-2 Bag10-566032025-07-15
30641043566033CPR-2 Bag10-566032025-07-15
10641043913161Neo-Tee T-Piece Resuscitator CircuitM1091316VSM1091316VS2024-02-08
10641043913352Neo-Tee T-Piece Resuscitator CircuitM1091335VSM1091335VS2024-02-08
10641043913659Neo-Tee T-Piece Resuscitator CircuitM1091365VSM1091365VS2024-02-08
10641043553701StatCO2 End Tidal CO2 Detector10-553702016-01-08
30641043913165Neo-Tee T-Piece Resuscitator Circuit10-913162024-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10788942547001PortexICU MEDICAL, INC.BXR2016-10-11
10788942548008PortexICU MEDICAL, INC.BXR2016-10-11
10788942560604PortexICU MEDICAL, INC.BXR2016-10-11
10788942560659PortexICU MEDICAL, INC.BXR2016-10-11
00026072011287Allied Medical LLCAllied Medical, LLCBXR2016-09-16
00260720011285Allied Healthcare Products Inc.ALLIED HEALTHCARE PRODUCTS, INC.BXR2016-09-16
M996BE14810BE 148-1 Gauge AdapterINSTRUMENTATION INDUSTRIES, INCORPORATEDBXR2016-07-29
M996BE14860BE 148-6 Gauge AdapterINSTRUMENTATION INDUSTRIES, INCORPORATEDBXR2016-07-29
M996BE14910BE 149-1 Gauge AdapterINSTRUMENTATION INDUSTRIES, INCORPORATEDBXR2016-07-29
M996NS120TRR0NS 120-TRR Negative Inspiratory Force (NIF) MeterINSTRUMENTATION INDUSTRIES, INCORPORATEDBXR2016-07-29
M996NS30PBR0NS 30-PBR Negative Inspiratory Force (NIF) MeterINSTRUMENTATION INDUSTRIES, INCORPORATEDBXR2016-07-29
M996NS30TRR0NS 30-TRR Negative Inspiratory Force (NIF) MeterINSTRUMENTATION INDUSTRIES, INCORPORATEDBXR2016-07-29
M996NS60PBR0NS 60-PBR Negative Inspiratory Force (NIF) MeterINSTRUMENTATION INDUSTRIES, INCORPORATEDBXR2016-07-29
M996NS60TBR0NS 60-TBR Negative Inspiratory Force (NIF) MeterINSTRUMENTATION INDUSTRIES, INCORPORATEDBXR2016-07-29
M996NS60TRR0NS 60-TRR Negative Inspiratory Force (NIF) MeterINSTRUMENTATION INDUSTRIES, INCORPORATEDBXR2016-07-29
M996NSGC0NS-GC Gauge CoverINSTRUMENTATION INDUSTRIES, INCORPORATEDBXR2016-07-29
M996NSGS0NS-GS Gauge StandINSTRUMENTATION INDUSTRIES, INCORPORATEDBXR2016-07-29
10641043340004NIFometerMERCURY ENTERPRISES, INC.BXR2016-04-01
10641043340028NIFometerMERCURY ENTERPRISES, INC.BXR2016-04-01
10641043340035NIFometerMERCURY ENTERPRISES, INC.BXR2016-04-01
30641043340008NIFometerMERCURY ENTERPRISES, INC.BXR2016-04-01
30641043340022NIFometerMERCURY ENTERPRISES, INC.BXR2016-04-01
30641043340039NIFometerMERCURY ENTERPRISES, INC.BXR2016-04-01