FDA.reportPublic FDA data

MEDLINE

Primary DI
20197344103734
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ854
Catalog number
DYNJ854
Device description
MOUTHPIECE,WHITE
Published
2024-07-22
Public version status
New
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
BYPMOUTHPIECE, BREATHING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYPMouthpiece, BreathingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20197344103734PrimaryGS10
10197344103737Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734410373420197344103734
1019734410373710197344103737

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function testing filter/mouthpieceA non-sterile, portable, screening device intended to be used during pulmonary function testing to remove and retain microdroplets from patient breath to reduce contamination of the parent device; it is also intended to function as a mouthpiece to facilitate access to the patient’s respiratory tract. It is a bidirectional filter, typically in a plastic housing, with a proximal port/mouthpiece; it may have a basic mouthpiece portion capable of being attached to a separate dedicated mouthpiece. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
50
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06420099000264M9242-100, SpiroSafe Disposable Flow TransducerMedikro OyBYP2026-04-21
06420099000318703419 Disposable Flow Transducer QTY 100Medikro OyBYP2026-04-21
06420099000325703418 Disposable Flow Transducer QTY 25Medikro OyBYP2026-04-21
06420099000332703417 Disposable Flow Transducer QTY 4Medikro OyBYP2026-04-21
06420099000622M9242-SP-90, SpiroSafe Disposable Flow TransducerMedikro OyBYP2026-04-21
08904461055031OSSEOUS-SnorOFFEON MEDITECH PRIVATE LIMITEDBYP2026-03-13
08904461055024OSSEOUS-SnorOFFEON MEDITECH PRIVATE LIMITEDBYP2026-03-13
06923980103674N/AGaleMed Xiamen Co., Ltd.BYP2025-12-23
46923980103672N/AGaleMed Xiamen Co., Ltd.BYP2025-12-23
10197344011315HUDSON RCIMEDLINE INDUSTRIES, INC.BYP2025-08-18
20197344011312HUDSON RCIMEDLINE INDUSTRIES, INC.BYP2025-08-18
14250892907373JaegerJaeger Medical GmbHBYP2025-06-02
14250892908080JaegerJaeger Medical GmbHBYP2025-06-02
34250892907360JaegerJaeger Medical GmbHBYP2025-06-02
04250892907321JaegerJaeger Medical GmbHBYP2025-06-02
10889483573457AirLife™AIRLIFEBYP2025-03-27
10889483569160AirLife™AIRLIFEBYP2025-03-18
10889483569191AirLife™AIRLIFEBYP2025-03-18
00817081028225Mouthpiece, Disposable, White, Thermoplastic, Bite Block StyleA-M SYSTEMS, LLCBYP2025-02-21
00817081028249Breathebite Mouthpiece, Disposable, Thermoplastic, Tongue DepressingA-M SYSTEMS, LLCBYP2025-02-21
07613365500127SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
07613365500141SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
07613365500202SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
20197344120342HUDSON RCIMEDLINE INDUSTRIES, INC.BYP2024-12-10
04719873130191Aerogen®GoHCMED INNOVATIONS CO., LTD.BYP2024-08-20
B279F0370050Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
B279F0370200Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
B279S298070050Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
B279S298070200Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
00384620000733InFloConeALLIANCE TECH MEDICAL INCBYP2023-09-08