FDA.reportPublic FDA data

Pressure Safe

Primary DI
10709078005746
Brand
Pressure Safe
Company
WESTMED, INC.
Model
9655PS
Device description
Pressure Safe CO-Flo, Disposable Heated Humidified Circuit Kit
Published
2018-06-25
Public version status
New
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
OGLOxygen Administration Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGLOxygen Administration KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10709078005746PackageGS110In Commercial Distribution
00709078005749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800574610709078005746
00709078005749007090780057497090780057490709078005749

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen administration kit, non-sterileA collection of non-sterile devices designed for oxygen (O2) delivery that may include a mask, a nasal cannula, oxygen tubing, disposable non-prefilled humidifier and connectors. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
092673953
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00709078008818Adaptors/Conectors208438822021-01-29
05707480103195Hyperinflation (AMBU)900 000 6032015-10-24
00709078003028Composite Kit07932017-04-26
00709078003868Humidifier Adaptor04852017-05-26
00709078003899Composite Kit07942017-05-26
00709078005954OxyGo Bubble Humidifier1425-10142018-09-25
00709078007606Bubble Humidifier04802021-02-24
00709078014093Bubble Humidifier10022832022-03-31
00709078014277Bubble Humidifier010-1048582022-03-31
00709078014284Bubble Humidifier10022482022-03-31
00709078003011Composite Kit07922017-04-26
00709078003158Bubble Humidifier07952017-04-26
00709078003349Mod Kit Pulset™3362-912017-03-30
00709078003356Pulset3363-912017-03-30
00709078003974A-Line3100-302021-01-31
00709078004483Pulset3373-912017-08-31
00709078004612Pulset™ 1cc Syringe31002021-04-28
00709078005107Pulset™3165-912017-09-22
00709078006470Pulset3303-502022-05-31
00709078009082Pulset3173-142020-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530109523Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-08-20
00848530109295Oxygen kitSunset Healthcare Solutions, Inc.OGL2026-06-11
00848530104443Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-04-22
00848530104450Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-04-22
00848530105402Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-04-22
00848530108915Repair PartsSunset Healthcare Solutions, Inc.OGL2026-04-22
00848530108922Repair PartsSunset Healthcare Solutions, Inc.OGL2026-04-22
00848530108908Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-04-20
00848530108595Repair PartsSunset Healthcare Solutions, Inc.OGL2026-04-13
00848530108601Repair LabelSunset Healthcare Solutions, Inc.OGL2026-04-13
00848530108526Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-04-07
00848530108533Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-04-07
00848530108625Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-04-07
00848530108762Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-04-07
00848530108649Repair PartsSunset Healthcare Solutions, Inc.OGL2026-03-17
00848530108663Repair PartsSunset Healthcare Solutions, Inc.OGL2026-03-17
00848530108687Repair PartsSunset Healthcare Solutions, Inc.OGL2026-03-17
10848530108646Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
10848530108660Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
10848530108684Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
00848530108571Repair PartsSunset Healthcare Solutions, Inc.OGL2026-03-09
00848530108588Repair PartsSunset Healthcare Solutions, Inc.OGL2026-03-09
00848530108434Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-02-18
00848530108311Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-02-11
00848530108304Repair PartsSunset Healthcare Solutions, Inc.OGL2026-01-26
00848530108229REPAIR PARTSunset Healthcare Solutions, Inc.OGL2026-01-19
00848530108243REPAIR PARTSunset Healthcare Solutions, Inc.OGL2026-01-19
00848530108250REPAIR PARTSunset Healthcare Solutions, Inc.OGL2026-01-19
10848530108226REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
00848530108236REPAIR PARTSSunset Healthcare Solutions, Inc.OGL2026-01-19