FDA.reportPublic FDA data

Portex

Primary DI
10788942560604
Brand
Portex
Company
ICU MEDICAL, INC.
Model
55-6060
Published
2016-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10788942560604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1078894256060410788942560604

GMDN Terms#

Term, Definition table
TermDefinition
Medical device pressure test meterAn electrically-powered electronic instrument designed to measure and establish the degree of positive or negative pressure (pneumatic or hydraulic) found in a medical device, piece of equipment, or system. It is connected to the device, equipment, or system with the unknown pressure via a hose or connector and the pressure is sensed by this device and converted into a digital pressure reading displayed in one of several units, e.g., mmHg, cmH2O, or pascal. It is typically used by a healthcare provider (i.e., clinical technician) in a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709203263BivonaFT26IN40NGE030N2026-09-04
10887709203270BivonaXT26IS70NSC031N2026-09-04
10887709203287BivonaFT26IN40NSF032N2026-09-04
10887709203294BivonaFT26IN50NSF034N2026-09-04
10887709203300BivonaFT26IN55NSF033N2026-09-04
10887709203324BivonaFT26IN30NSE036N2026-09-04
10887709201641BivonaZT26DN50NSZ214S2026-08-27
10887709202174BivonaST26HN80ZSZ137N2026-08-27
10887709202426BivonaFT26HN45NSF207N2026-08-27
10887709202433BivonaFU26HN40NGF213N2026-08-27
10887709202440BivonaFT26HN45NGA211N2026-08-27
10887709202464BivonaFT26HN30NGE215N2026-08-27
10887709202471BivonaFT26HN35NGE214N2026-08-27
10887709202259BivonaFU26HN35NGA187N2026-08-26
10887709202266BivonaFT26HN35NGE188N2026-08-26
10887709202273BivonaFU26HN40NGA186N2026-08-26
10887709202280BivonaFT26HN35NGF189N2026-08-26
10887709202297BivonaFU26HN40NGF190N2026-08-26
10887709202303BivonaFT26HN40NSE076N2026-08-26
10887709202310BivonaFU26HN25NGE191N2026-08-26

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
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
30641043340039NIFometerMERCURY ENTERPRISES, INC.BXR2016-04-01