FDA.reportPublic FDA data

Mouthpiece, Disposable Flex, 1-3/8" OD, 2.625" L

Primary DI
00817081023862
Brand
Mouthpiece, Disposable Flex, 1-3/8" OD, 2.625" L
Company
A-M SYSTEMS, LLC
Model
Mouthpiece, Flex, 1-3/8" OD, 2.625" L - 162803
Catalog number
162803
Device description
Mouthpiece, Disposable Flex, 1-3/8" OD, 2.625" L
Published
2020-01-03
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
00817081023862PackageGS1100In Commercial Distribution
00817081023855PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817081023862008170810238628170810238620817081023862
00817081023855008170810238558170810238550817081023855

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
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817081028553VBMax28s, PF Testing Filter Labeled DR BurtonVBMax28s, DR Burton - VBMax28s1369042025-08-07
00817081028577VBMax28e, PF Testing Filter Labeled DR BurtonVBMax28e, DR Burton - VBMax28e1469042025-08-07
00817081028515VBMAX34, DISPOSABLE PF TESTING FILTERVBMAX34 - 1564002025-06-25
00817081028539PFT KIT J, VBMax34S w/ Blue Rubber Nose clipPFT KIT J, VBMax34S - 1871741871742025-06-25
00817081028492VBMax34, PF Testing Filter Labeled DR BurtonVBMax34, PF Testing Filter - 1564041564042025-06-03
00817081028478PFT Kit B, VBMax35PFT Kit B, VBMax35 - 1801141801142025-05-12
00817081028454PFT Kit J, VBMax31SPFT Kit J, VBMax31S - 1871411871412025-05-02
00817081028416VBMax28, PF Testing FilterVBMax28, PF Testing Filter - 1569041569042025-04-03
00817081028430PFT Kit B, VBMax35 w/ Blue Foam Nose clipPFT Kit B, VBMax35 - 1801151801152025-04-03
00817081028393PFT Kit I, VBMax36S w/ Foam Nose Clip and 164900PFT Kit I, VBMax36S - 1872661872662025-04-02
00817081028379PFT Kit B, VBMax48PFT Kit B, VBMax48 - 1881021881022025-03-24
00817081028355Pulmonary Function Test Kit EPulmonary Function Test Kit E - 1891241891242025-02-28
00817081028270PFT Kit E, VBMax36E PFT Kit E, VBMax36E - 1891391891392025-02-25
00817081028294Disposable White PFT Nose Clip with Rubber Pads, Labeled D R BurtonDisposable White PFT Nose Clip with Rubber Pads - 1660042025-02-25
00817081028317Disposable Blue PFT Nose Clip with Rubber PadsDisposable Blue PFT Nose Clip - 1667041667042025-02-25
00817081028331Disposable Blue PFT Nose Clip with Foam PadsDisposable Blue PFT Nose Clip with Foam Pads - 1661669042025-02-25
00817081028232Mouthpiece, Disposable, White, Thermoplastic, Bite Block StyleDisposable Mouthpiece, Bite Block Style - 1649041649042025-02-21
00817081028256Breathebite Mouthpiece, Disposable, Thermoplastic, Tongue DepressingBreathebite Mouthpiece - 1649541649542025-02-21
00817081028218PFT Nose Clip with Foam PadsPFT Nose Clip with Foam Pads1665042025-02-20
00817081028195Pulmonary Function Test Kit EPFT Kit E - 1891251891252025-02-18

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Primary DI, Brand, Company table
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00817081028256Breathebite Mouthpiece, Disposable, Thermoplastic, Tongue DepressingA-M SYSTEMS, LLCBYP2025-02-21
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