FDA.reportPublic FDA data

HUDSON RCI

Primary DI
44026704659386
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN913732
Catalog number
2417
Device description
COMFORT FLO® Cannula Adaptor
Published
2023-06-16
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZACONNECTOR, AIRWAY (EXTENSION)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
44026704659386PackageGS150In Commercial Distribution
14026704659385PreviousGS10
34026704659389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4402670465938644026704659386
1402670465938514026704659385
3402670465938934026704659389

GMDN Terms#

Term, Definition table
TermDefinition
Straight/elbow breathing circuit connector, single-useA device intended to create a direct connection between a breathing circuit breathing tube and an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with specific connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It is typically made of plastic materials and can have a straight or elbow-shaped design (excludes Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. 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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
06923980112799MindrayGaleMed Xiamen Co., Ltd.BZA2026-05-26
06944904007236MindrayGaleMed Xiamen Co., Ltd.BZA2026-05-26
16923980103206N/AGaleMed Xiamen Co., Ltd.BZA2026-05-25
20197344009807HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-03-19
44710810084858N/AGALEMED CORPORATIONBZA2026-03-05
44710810086548N/AGALEMED CORPORATIONBZA2026-03-05
44710810102453N/AGALEMED CORPORATIONBZA2026-03-05
44710810104037N/AGALEMED CORPORATIONBZA2026-03-05
44710810110731N/AGALEMED CORPORATIONBZA2026-03-05
44710810082601N/AGALEMED CORPORATIONBZA2026-03-04
44710810083929N/AGALEMED CORPORATIONBZA2026-03-04
44710810086753N/AGALEMED CORPORATIONBZA2026-03-04
44710810087187N/AGALEMED CORPORATIONBZA2026-03-04
44710810104563N/AGALEMED CORPORATIONBZA2026-03-04
44710810107328N/AGALEMED CORPORATIONBZA2026-03-04
44710810111417N/AGALEMED CORPORATIONBZA2026-03-04
44710810115941N/AGALEMED CORPORATIONBZA2026-03-04
00619498004409HumidAirRESMED PTY LTDBZA2026-02-09
04048675034643Connector M34X1.5, 9/16Drägerwerk AG & Co. KGaABZA2026-02-04
04048675034735Adapter 9/16" to 6mmDrägerwerk AG & Co. KGaABZA2026-02-04
20197344012005HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344012432HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344012463HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344012593HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344042323HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
46923980107748N/AGaleMed Xiamen Co., Ltd.BZA2025-12-24
46923980107281N/AGaleMed Xiamen Co., Ltd.BZA2025-12-23
20889483225254AirLife™SUNMED, LLCBZA2025-12-22
20889483225223Adapters/ConnectorsSUNMED, LLCBZA2025-12-18
20889483225278AirLife™SUNMED, LLCBZA2025-12-18