FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50885380100152
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
BBD2000LF
Catalog number
BBD2000LF
Device description
BAG BREATHING 2L DIPPED Not Made with Natural Rubber Latex
Published
2019-05-20
Public version status
Update
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
50885380100152PackageGS130In Commercial Distribution
10885380100154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538010015250885380100152
1088538010015410885380100154

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
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06923980111907MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112614MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112621MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112638MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112805MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112829MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
20889483560959Vital Signs™SUNMED, LLCBTC2025-12-31
20889483560942Vital Signs™SUNMED, LLCBTC2025-12-30
20889483560935Vital Signs™SUNMED, LLCBTC2025-12-19
20885632455435Halyard Breathing BagAIRLIFEBTC2025-07-25
20885632455411Halyard Breathing BagAIRLIFEBTC2025-07-18
20885632455428Halyard Breathing BagAIRLIFEBTC2025-07-18
10889483642412Vital Signs Breathing BagAIRLIFEBTC2025-07-18
10889483642429Vital Signs Breathing BagAIRLIFEBTC2025-07-18
10889483642436Vital Signs Breathing BagAIRLIFEBTC2025-07-18
10889483642443Vital Signs Breathing BagAIRLIFEBTC2025-07-18
20629160000350FEATHER-FLEXBOMImed IncBTC2025-07-14
46923980115552MindrayGaleMed Xiamen Co., Ltd.BTC2025-06-23
10889483602492Vital Signs™AirLife Finland OyBTC2025-04-04
20889483601706Vital Signs™AirLife Finland OyBTC2025-04-01
20889483601713Vital Signs™AirLife Finland OyBTC2025-04-01
20889483601720Vital Signs™AirLife Finland OyBTC2025-04-01
20889483601737Vital Signs™AirLife Finland OyBTC2025-04-01
20889483620073Vital Signs™AirLife Finland OyBTC2025-04-01
20889483602505Vital Signs™AirLife Finland OyBTC2025-03-28
20889483602512Vital Signs™AirLife Finland OyBTC2025-03-28
30889483584808Vital Signs™Sunmed Group Holdings, LLCBTC2025-03-06
30889483584822Vital Signs™Sunmed Group Holdings, LLCBTC2025-03-06
06972249260085Breathing bagsShandong Jinlai Huanhai Medical Technology Co., Ltd.BTC2025-03-03
06972249260092Breathing bagsShandong Jinlai Huanhai Medical Technology Co., Ltd.BTC2025-03-03