FDA.reportPublic FDA data

Halyard Breathing Bag

Primary DI
20885632455411
Brand
Halyard Breathing Bag
Company
AIRLIFE
Model
ABC3001
Device description
Halyard Breathing Bag
Published
2025-07-18
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
BTCBag, Reservoir

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTCBag, ReservoirAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885632455411PackageGS140In Commercial Distribution
10885632455414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088563245541120885632455411
1088563245541410885632455414

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit bag, single-useA non-sterile elastomeric reservoir sac intended to store breathing gas during the respiratory cycle. The breathing bag may be on the inspiratory or expiratory limb of a breathing circuit depending on the breathing circuit design. It may also function as a maximum pressure limiting device during spontaneous or manually assisted ventilation. It may be made of conductive or non-conductive material and is typically used in anaesthesia or ventilator breathing circuits. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119058668
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
10889483586358Vital Signs™5503B5503B2025-02-18
10889483570906AirLife™0020030020032025-02-20
10889483570913Airlife™ Bubble Humidifier with 6 psi Pressure Relief Valve0020060020062025-02-20
10889483571477Airlife™ Sterile Water for Inhalation, USP, 500 ml0026200026202025-02-20
10889483617007AirLife™RC6Y023034RC6Y0230342025-02-27
10889483618264Air LifeAM-20002026-08-26
10889483618271Air LifeAM-21002026-08-26
10889483618288Air LifeAM-22002026-08-26
10889483618295Air LifeAM-30002026-08-26
10889483618301Air LifeAM-31002026-08-26
10889483618318Air LifeAM-32002026-08-26
10190752118379Vital Signs™2L39882L39882019-12-20
10190752118430Vital Signs™5030AE5030AE2020-02-20
10190752118973Vital Signs™5236AAE5236AAE2019-12-20
10190752119017Vital Signs™5372AE5372AE2019-12-20
10190752119215Vital Signs™A1UXOXXXA1UXOXXX2019-12-20
10190752119246Vital Signs™A1ZX1XXXA1ZX1XXX2020-02-20
10190752119369Vital Signs™A46517XXA46517XX2019-12-20
10190752119437Vital Signs™A46X8XXXA46X8XXX2019-12-20
10190752119628Vital Signs™A4FX1XXXA4FX1XXX2019-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
080516845801133 L NON STERILE WASTE BAGSMOZARC MEDICAL ITALY SRLBTC2026-07-30
04719874950446Create BiotechCREATE BIOTECH CO., LTD.BTC2026-07-21
04719874950781Create BiotechCREATE BIOTECH CO., LTD.BTC2026-07-21
04719874952440Create BiotechCREATE BIOTECH CO., LTD.BTC2026-07-21
04816415501430BREATHING BAG single use 500ASSOMEDIKA, OOOBTC2026-05-27
04816415501447BREATHING BAG single use 1000ASSOMEDIKA, OOOBTC2026-05-27
04816415501454BREATHING BAG single use 2000ASSOMEDIKA, OOOBTC2026-05-27
04816415501461BREATHING BAG single use 3000ASSOMEDIKA, OOOBTC2026-05-27
04816415501478BREATHING BAG reusable 500ASSOMEDIKA, OOOBTC2026-05-27
04816415501485BREATHING BAG reusable 1000ASSOMEDIKA, OOOBTC2026-05-27
04816415501492BREATHING BAG reusable 2000ASSOMEDIKA, OOOBTC2026-05-27
04816415501508BREATHING BAG reusable 3000ASSOMEDIKA, OOOBTC2026-05-27
08697645018198ENDURE INDUSTRIESENDURE INDUSTRIESBTC2026-04-17
00848530099084AnesthesiaSunset Healthcare Solutions, Inc.BTC2025-10-30
10629160000346FEATHER-FLEXBOMImed IncBTC2025-07-14
10629160000339FEATHER-FLEXBOMImed IncBTC2024-03-01
10080196984190Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984213Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984251Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984770Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984787Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984848Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984855Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984916Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984930Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389001943Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389004999Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389005002Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389380932Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389382615Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04