FDA.reportPublic FDA data

Disposable Hyperinflation System

Primary DI
00709078011481
Brand
Disposable Hyperinflation System
Company
WESTMED, INC.
Model
7-N7905-I-MAN-P
Device description
Hyperinflation, System, 1/2L Bag (Letx Free), 7' O2 and Manometer, Infant Mask, 40 CM pop off Valve
Published
2020-11-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BZRMixer, Breathing Gases, Anesthesia Inhalation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZRMixer, Breathing Gases, Anesthesia InhalationAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K932709000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K932709000PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEMPrecision Med Products, Ltd.1993-07-23BZR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10709078011488PackageGS112In Commercial Distribution
00709078011481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907801148810709078011488
00709078011481007090780114817090780114810709078011481

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
092673953
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00709078011849A-Line3300-242020-09-30
00709078011863A-Line3100-202020-09-30
00709078011900A-Line3300-262020-09-30
00709078012013Pulset36002020-09-30
00709078012037Pulset3600-202020-09-30
00709078013287Atellica® VTR Syringes115613402022-02-28
00709078013300Atellica® VTR Syringes115613412022-02-28
00709078013324Atellica® VTR Syringes115613422022-02-28
00709078013348Atellica® VTR Syringes115613432022-02-28
00709078013362Atellica® VTR Syringes115613442022-02-28
00709078013386Atellica® VTR Syringes115613452022-02-28
00709078013409Atellica® VTR Syringes115613462022-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260635790660AirTechniquesBaldus Sedation GmbH & Co. KGBZR2026-05-11
04260635790776AirTechniquesBaldus Sedation GmbH & Co. KGBZR2026-05-11
04260635790783AirTechniquesBaldus Sedation GmbH & Co. KGBZR2026-05-11
04260635790790AirTechniquesBaldus Sedation GmbH & Co. KGBZR2026-05-11
10889483528600AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483528723AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483528747AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483528853AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483528938AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483542774AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483542798AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483542835AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483542859AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483542873AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483542910AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483542958AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483528614AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483528737AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483528751AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483528867AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483528942AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483568795AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483542801AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483542849AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483542863AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483542887AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483542924AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483542962AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483222157AmbuSUNMED, LLCBZR2025-12-19
10889483222164AmbuSUNMED, LLCBZR2025-12-19