FDA.reportPublic FDA data

Spirometrics

Primary DI
00855784004283
Brand
Spirometrics
Company
Spirometrics
Model
D1020
Device description
Adult Mouthpiece, each
Published
2017-04-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00855784004092PackageGS1200Not in Commercial Distribution
00855784004108PackageGS12Not in Commercial Distribution
00855784004115PackageGS15Not in Commercial Distribution
00855784004122PackageGS1100Not in Commercial Distribution
00855784004139PackageGS14Not in Commercial Distribution
00855784004146PackageGS110Not in Commercial Distribution
00855784004283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855784004092008557840040928557840040920855784004092
00855784004108008557840041088557840041080855784004108
00855784004115008557840041158557840041150855784004115
00855784004122008557840041228557840041220855784004122
00855784004139008557840041398557840041390855784004139
00855784004146008557840041468557840041460855784004146
00855784004283008557840042838557840042830855784004283

GMDN Terms#

Term, Definition table
TermDefinition
Breathing mouthpiece, single-useA device designed for partial insertion into a patient's mouth (in between the lips) 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 enables an appropriate gastight seal 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); connectors and filters may be included with the device. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-207-657-6700info@spirometrics.com

Regulatory Flags#

DUNS number
830864406
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855784004009VeinsiteVTS10002018-12-04
00855784004269Spiro-FilterD10102016-10-11
00855784004276SpirometricsD10302017-04-03
00855784004016SpiroFlowE5010E5010-22016-10-11
00855784004047SpiroFlowE5020E5020-22016-10-11
00855784004290SpirometricsD10602017-04-03
00855784004207SpirometricsN4010N4010-22017-04-03
00855784004214SpirometricsN4010N4010-2-VAC2017-04-03
00855784004245SpiroFlowE5010E5010-2-NOV2016-10-11
00855784004252SpiroFlowE5020E5020-2-NOV2016-10-11
00855784004085Spiro-FilterD10102016-10-11
00855784004160SpirometricsD10302017-04-03
00855784004146SpirometricsD10202017-04-03
00855784004030SpiroFlowE5010E5010-22016-10-11
00855784004054SpiroFlowE5020E5020-22016-10-11
00855784004191SpirometricsD10602017-04-03

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
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