FDA.reportPublic FDA data

Hyperinflation AMBU

Primary DI
05707480137527
Brand
Hyperinflation AMBU
Company
WESTMED, INC.
Model
900 000 614
Device description
Disposable Hyperinflation System, 1/2 Bag 7' O2 and Manometer 40 cm H2O Pop-Off Valve
Published
2019-07-24
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
05707480137534PackageGS112In Commercial Distribution
05707480137527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707480137534057074801375345707480137534
05707480137527057074801375275707480137527

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
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00709078007781Composite Respiratory Kit07992019-10-18
00709078012693Septal-H Infant SizeCP-5500A2021-10-08
00709078012716Septal-H Pediatric SizeCP-5510A2021-10-08
00709078012990CapetteCP-42012021-06-25
00709078013003CapetteCP-42022021-06-25
00709078013010CapetteCP-42032021-06-25
00709078013027CapetteCP-44012021-06-25
00709078013034CapetteCP-44022021-06-25
00709078013041CapetteCP-44032021-06-25
00709078013058StrapetteCP-42042021-06-25
00709078013065StrapetteCP-42202021-06-25
00709078013072StrapetteCP-44042021-06-25
00709078013089StrapetteCP-44202021-06-25
00709078013096ChinstrapCP-51002021-06-25
00709078013102ChinstrapCP-52002021-06-25
00709078013119Septal-HCP-54002021-06-30
00709078013126Septal-HCP-54102021-06-30
00709078013133Septal-HCP-55002021-06-30
00709078013140Septal-HCP-55102021-06-30
00709078013157SavEarRT-61002021-06-25

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