FDA.reportPublic FDA data

9061 MOUTHPIECE

Primary DI
00874750004102
Brand
9061 MOUTHPIECE
Company
HANS RUDOLPH, INC.
Model
9061
Catalog number
602076
Device description
MOUTHPIECE SM BITE MATE 22MM
Published
2018-11-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00874750004102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00874750004102008747500041028747500041020874750004102

GMDN Terms#

Term, Definition table
TermDefinition
Breathing mouthpiece, reusableA 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. The device is typically attached, either directly or through other tubes/adapters, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser). Some types generate a whistling sound to guide effective inhalation [e.g., during use of a metered dose inhaler (MDI)]. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007131725
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008171360277395530 3L SYRINGE55301139752026-05-01
008171360277465530 3L SYRINGE55301139762026-05-01
008171360277227450 RV2 MASK7450CC16412025-10-16
008171360277157450 RV2 MASK74502018412025-09-19
008171360272417450 RV2 MASK74506122212023-04-05
008171360272587450 RV2 MASK74506122442023-04-05
008171360272657450 RV2 MASK74506123992023-04-05
008171360272967450 RV2 MASK74506127812023-04-05
008171360273337450 RV2 MASK74506128642023-04-05
008171360273957450 RV2 MASK7450CC17342023-04-05
008171360274017450 RV2 MASK7450CC17482023-04-05
008747500027957450 RV2 MASK74502015192023-04-05
008171360276927450 RV2 MASK74501138822024-07-15
008171360277087450 RV2 MASK74501138852024-07-15
008171360270127450 RV2 MASK74501136932022-11-08
008171360268177450 RV2 MASK74501138832022-03-10
008171360268247450 RV2 MASK74501138842022-03-10
008171360267947450 RV2 MASK74501138052022-02-22
008171360267567450 RV2 MASK74501138012021-10-04
008171360262067450 RV2 MASK74501138552019-07-08

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
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
20197344103734MEDLINEMEDLINE INDUSTRIES, INC.BYP2024-07-22
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