FDA.reportPublic FDA data

Disposable Cardboard Mouthpiece

Primary DI
10817081021346
Brand
Disposable Cardboard Mouthpiece
Company
A-M SYSTEMS, LLC
Model
Disposable Cardboard Mouthpiece - 162608
Catalog number
162608
Device description
"MOUTHPIECE, DISPOSABLE CARDBOARD, 1-3/16"" OD,2.625"" L - Case 2400"
Published
2018-06-01
Public version status
Update
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
10817081021346PrimaryGS10
00817081021349Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081708102134610817081021346
00817081021349008170810213498170810213490817081021349

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
3606838300sales@a-msystems.com

Regulatory Flags#

DUNS number
020275145
Device count
100
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817081028621Pulmonary Function Test Kit B, 36 MM O.D.PFT KIT B - 1841141841142026-04-24
00817081028607PFT Kit B, Disposable, 34 MMPFT Kit B, Disposable, 34 MM - 1831021831022025-11-06
00817081028584VBMax30E, Disposable PF Testing FilterVBMax30E - 1463091463092025-10-20
00817081028546VBMax28s, PF Testing Filter Labeled DR BurtonVBMax28s, DR Burton - VBMax28s1369042025-08-07
00817081028560VBMax28e, PF Testing Filter Labeled DR BurtonVBMax28e, DR Burton - VBMax28e1469042025-08-07
00817081028553VBMax28s, PF Testing Filter Labeled DR BurtonVBMax28s, DR Burton - VBMax28s1369042025-08-07
00817081028577VBMax28e, PF Testing Filter Labeled DR BurtonVBMax28e, DR Burton - VBMax28e1469042025-08-07
00817081028508VBMAX34, DISPOSABLE PF TESTING FILTERVBMAX34 - 1564002025-06-25
00817081028522PFT KIT J, VBMax34S w/ Blue Rubber Nose clipPFT KIT J, VBMax34S - 1871741871742025-06-25
00817081028515VBMAX34, DISPOSABLE PF TESTING FILTERVBMAX34 - 1564002025-06-25
00817081028539PFT KIT J, VBMax34S w/ Blue Rubber Nose clipPFT KIT J, VBMax34S - 1871741871742025-06-25
00817081028485VBMax34, PF Testing Filter Labeled DR BurtonVBMax34, PF Testing Filter - 1564041564042025-06-03
00817081028492VBMax34, PF Testing Filter Labeled DR BurtonVBMax34, PF Testing Filter - 1564041564042025-06-03
00817081028461PFT Kit B, VBMax35PFT Kit B, VBMax35 - 1801141801142025-05-12
00817081028478PFT Kit B, VBMax35PFT Kit B, VBMax35 - 1801141801142025-05-12
00817081028447PFT Kit J, VBMax31SPFT Kit J, VBMax31S - 1871411871412025-05-02
00817081028454PFT Kit J, VBMax31SPFT Kit J, VBMax31S - 1871411871412025-05-02
00817081028409VBMax28, PF Testing FilterVBMax28, PF Testing Filter - 1569041569042025-04-03
00817081028423PFT Kit B, VBMax35 w/ Blue Foam Nose clipPFT Kit B, VBMax35 - 1801151801152025-04-03
00817081028416VBMax28, PF Testing FilterVBMax28, PF Testing Filter - 1569041569042025-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
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B279S298070050Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
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