FDA.reportPublic FDA data

NIFometer

Primary DI
30641043340039
Brand
NIFometer
Company
MERCURY ENTERPRISES, INC.
Model
10-34003
Published
2016-04-01
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
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
30641043340039PackageGS110In Commercial Distribution
10641043340035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3064104334003930641043340039
1064104334003510641043340035

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

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
10641043340011NIFometerMERCURY ENTERPRISES, INC.BXR2016-04-01
30641043340022NIFometerMERCURY ENTERPRISES, INC.BXR2016-04-01