FDA.reportPublic FDA data

HUDSON RCI

Primary DI
14026704594853
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN042595
Catalog number
1565
Device description
Mouthpiece 15 mm O.D. / 22 mm O.D.
Published
2020-01-29
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
BYPMOUTHPIECE, BREATHING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYPMouthpiece, BreathingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14026704594853PackageGS150Not in Commercial Distribution
34026704594857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1402670459485314026704594853
3402670459485734026704594857

GMDN Terms#

Term, Definition table
TermDefinition
Breathing mouthpiece, single-useA device designed to be inserted into a patient's mouth to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that provides an appropriate gastight seal (i.e., with a patient's lips) and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector). 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
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46923980103672N/AGaleMed Xiamen Co., Ltd.BYP2025-12-23
20197344011312HUDSON RCIMEDLINE INDUSTRIES, INC.BYP2025-08-18
04250892907321JaegerJaeger Medical GmbHBYP2025-06-02
04250892907383JaegerJaeger Medical GmbHBYP2025-06-02
30889483573451AirLife™Sunmed Group Holdings, LLCBYP2025-03-27
30889483569164AirLife™Sunmed Group Holdings, LLCBYP2025-03-18
30889483569195AirLife™Sunmed Group Holdings, LLCBYP2025-03-18
00817081028232Mouthpiece, Disposable, White, Thermoplastic, Bite Block StyleA-M SYSTEMS, LLCBYP2025-02-21
00817081028256Breathebite Mouthpiece, Disposable, Thermoplastic, Tongue DepressingA-M SYSTEMS, LLCBYP2025-02-21
14250892906833VyaireVyaire Medical GmbHBYP2025-01-07
14250892906840VyaireVyaire Medical GmbHBYP2025-01-07
14250892906857VyaireVyaire Medical GmbHBYP2025-01-07
14250892906864VyaireVyaire Medical GmbHBYP2025-01-07
07613365500110SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
07613365500134SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
07613365500196SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
00026072026304BFAllied Medical, LLCBYP2024-10-11
08052990320219MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABYP2024-09-10
08052990321179MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABYP2024-09-10
08052990321834MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABYP2024-09-10
10197344103737MEDLINEMEDLINE INDUSTRIES, INC.BYP2024-07-22
00026072026243BFAllied Medical, LLCBYP2024-05-28
00026072026298BFAllied Medical, LLCBYP2024-05-28
B279F037005001Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
B279F037020002Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
B279S29807005001Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
B279S29807020002Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
00817081027686Adapter, Tube, Sample PackA-M SYSTEMS, LLCBYP2023-11-21
10384620000730InFloConeALLIANCE TECH MEDICAL INCBYP2023-09-08