FDA.reportPublic FDA data

Mask, Face, Small Adult, w/Valve

Primary DI
00817081025866
Brand
Mask, Face, Small Adult, w/Valve
Company
A-M SYSTEMS, LLC
Model
Mask, Face, Small Adult, w/Valve - 167901
Catalog number
167901
Device description
Mask, Face, Small Adult, w/Valve
Published
2020-03-26
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
BYGMask, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817081025873PackageGS130In Commercial Distribution
00817081025866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817081025873008170810258738170810258730817081025873
00817081025866008170810258668170810258660817081025866

GMDN Terms#

Term, Definition table
TermDefinition
Rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It is made of non-conductive, soft, flexible polymers available in a range of sizes, and designed to create an airtight seal against the patient's face. The device may include tubing and various valves and connectors which may allow for connection to a central vacuum system to enable scavenging of residual (waste) anaesthetic gas from a patient in recovery; other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
3606838300sales@a-msystems.com

Regulatory Flags#

DUNS number
020275145
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817081028683PFT KIT F, VBMax 35e Filter KitPFT KIT F, VBMax 35e - 1891751891752026-07-17
00817081028669PFT Kit J, 31s VBMax Filter with Blue Foam Nose ClipPFT Kit J, 31s VBMax - 1871921971922026-06-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874950675Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874950972Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874951153Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874951160Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874951177Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874951184Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874955793Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874955809Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874955816Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956264Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956271Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956288Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956295Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956301Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956318Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
00607411919039Salter Labs® High Concentration partial rebreatherSALTER LABSBYG2026-06-10
00607411919336Salter Labs® Percent-O2-Lock® MaskSALTER LABSBYG2026-06-10
00607411919008Salter Labs® Adult Comfort Face TentSALTER LABSBYG2026-06-09
00607411919053Salter Labs® Oxygen MaskSALTER LABSBYG2026-06-09
00607411919060Salter Labs® Oxygen MaskSALTER LABSBYG2026-06-09
04816415501379LARYNGEAL MASK Single Use Size 2ASSOMEDIKA, OOOBYG2026-05-27
04816415501386LARYNGEAL MASK Single Use Size 3ASSOMEDIKA, OOOBYG2026-05-27
04816415501393LARYNGEAL MASK Single Use Size 5ASSOMEDIKA, OOOBYG2026-05-27
08697645018129ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018136ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018143ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
09420012427632Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
09420012428585Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
10885632467400HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467417HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29