FDA.reportPublic FDA data

RUSCH

Primary DI
24026704549478
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN044016
Catalog number
22194AP
Device description
Neoprene Pecan Shaped Breathing Bag with 22 mm neck insert
Published
2018-09-15
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

Contact Domains#

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
24026704549478PackageGS1100Not in Commercial Distribution
04026704549474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670454947824026704549478
04026704549474040267045494744026704549474

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

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
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
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

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