FDA.reportPublic FDA data

HUDSON RCI

Primary DI
04026704387939
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN044958
Catalog number
5423
Device description
Breathing Bag, 3 Liter
Published
2018-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
24026704387933PackageGS120Not in Commercial Distribution
04026704387939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670438793324026704387933
04026704387939040267043879394026704387939

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.

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
1
Premarket exempt
true
Lot or batch
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902228205ARROWIPNB00283ASK-45703-NCC32026-09-25
10801902228212ARROWIPNB00282ASK-45802-NCC2026-09-25
10801902228700ARROWCDC-09903-1ACDC-09903-1A2026-09-22
10801902228717ARROWCDA-42703-XPCN1ACDA-42703-XPCN1A2026-09-22
04026704916955RUSCHIPN9007315640002026-08-03
10841156111519TELEFLEXIPN93068158822025-06-12
10841156111540TELEFLEXIPN93068258842025-06-12
10841156111595TELEFLEXIPN93068458882025-06-12
10841156111755TELEFLEXIPN93068358862025-06-12
14026704302182RUSCHIPN0505091807051202016-09-16
14026704302205RUSCHIPN0505111807051402016-09-16
14026704302229RUSCHIPN0505131807051602016-09-16
14026704302243RUSCHIPN0505151807051802016-09-16
14026704302267RUSCHIPN0505171807052002016-09-16
14026704302281RUSCHIPN0505191807052202016-09-16
14026704302304RUSCHIPN0505211807052402016-09-16
14026704302328RUSCHIPN0505231807052602016-09-16
14026704302342RUSCHIPN0505251807052802016-09-16
14026704302366RUSCHIPN0505271807053002016-09-16
14026704302977RUSCHIPN0505911834052002016-09-16

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