FDA.reportPublic FDA data

Hyperinflation (AMBU)

Primary DI
05707480103218
Brand
Hyperinflation (AMBU)
Company
WESTMED, INC.
Model
900 000 601
Device description
Disposable Hyperinflation System, 3L Bag (Latex Free), 7' O2 and Pressure Lines
Published
2015-10-24
Public version status
Update
Distribution status
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
05707480103089PackageGS112In Commercial Distribution
05707480103218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707480103089057074801030895707480103089
05707480103218057074801032185707480103218

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

Regulatory Flags#

DUNS number
092673953
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
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