Allied Healthcare Products Inc.

Primary DI
00260720011285
Brand
Allied Healthcare Products Inc.
Company
ALLIED HEALTHCARE PRODUCTS, INC.
Model
890060
Catalog number
890060
Device description
Manometer
Published
2016-09-16
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

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
K003497000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003497000DISPOSABLE PRESSURE MONITOREngineered Medical Systems2000-11-30CAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00260720011285PrimaryGS10
40260720011283Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00260720011285002607200112852607200112850260720011285
4026072001128340260720011283

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

Regulatory Flags#

DUNS number
099674145
Device count
12
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
40026072025220pc55-01-0014-KZ2023-12-11
40026072025237PC55-01-0014-RU2023-12-11
40026072025244PC55-01-00152023-12-11
40026072025251PC55-01-00162023-12-11
40026072025268PC55-01-00172023-12-11
40026072025275PC55-01-00182023-12-11
40026072025282PC55-01-00192023-12-11
40026072025305PC55-01-00252023-12-11
40026072025312PC55-01-00262023-12-11
40026072025329PC55-01-00272023-12-11
40026072025336PC55-01-00282023-12-11
00260720010523VACUTRON22-18-16082016-08-09
00260720010745Vacutron22-19-16082016-08-26
00260720009374VACUTRONMINI-VAC22-16-16082016-09-12
00260720002627Chemtron219000-2322-10-00022016-09-09
00260720002634Chemtron219000-4322-10-00042016-09-09
00260720002641Chemtron219000-03-RPL22-10-00082016-09-09
00260720011544SchucoS1160-RPLS1160-RPL2016-09-15
00260720011551SchucoS1160A-RPLS1160A-RPL2016-09-15
00260720011568SchucoS1160B-MED2S1160B-MED22016-09-15

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
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
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M996NSGS0NS-GS Gauge StandINSTRUMENTATION INDUSTRIES, INCORPORATEDBXR2016-07-29
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