FDA.reportPublic FDA data

Breathing bags

Primary DI
06972249260221
Brand
Breathing bags
Company
Shandong Jinlai Huanhai Medical Technology Co., Ltd.
Model
HH-HHN-AT-5L
Published
2025-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
06972249260221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972249260221069722492602216972249260221

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
Ethylene Oxide

Regulatory Flags#

DUNS number
420187530
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972249260085Breathing bagsHH-HHN-A-0.25L2025-03-03
06972249260092Breathing bagsHH-HHN-A-4L2025-03-03
06972249260108Breathing bagsHH-HHN-A-5L2025-03-03
06972249260115Breathing bagsHH-HHN-A-6L2025-03-03
06972249260122Breathing bagsHH-HHN-B-0.25L2025-03-03
06972249260139Breathing bagsHH-HHN-B-4L2025-03-03
06972249260146Breathing bagsHH-HHN-B-5L2025-03-03
06972249260153Breathing bagsHH-HHN-B-6L2025-03-03
06972249260160Breathing bagsHH-HHN-AT-0.25L2025-03-03
06972249260177Breathing bagsHH-HHN-AT-0.5L2025-03-03
06972249260184Breathing bagsHH-HHN-AT-1L2025-03-03
06972249260191Breathing bagsHH-HHN-AT-2L2025-03-03
06972249260207Breathing bagsHH-HHN-AT-3L2025-03-03
06972249260214Breathing bagsHH-HHN-AT-4L2025-03-03
06972249260238Breathing bagsHH-HHN-AT-6L2025-03-03
06972249260245Breathing bagsHH-HHN-ATW-0.25L2025-03-03
06972249260252Breathing bagsHH-HHN-ATW-0.5L2025-03-03
06972249260269Breathing bagsHH-HHN-ATW-1L2025-03-03
06972249260276Breathing bagsHH-HHN-ATW-2L2025-03-03
06972249260283Breathing bagsHH-HHN-ATW-3L2025-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10885632455438Halyard Breathing BagAIRLIFEBTC2025-07-25
10885632455414Halyard Breathing BagAIRLIFEBTC2025-07-18
10885632455421Halyard Breathing BagAIRLIFEBTC2025-07-18
10629160000346FEATHER-FLEXBOMImed IncBTC2025-07-14
10629160000339FEATHER-FLEXBOMImed IncBTC2024-03-01
10080196984190Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
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