FDA.reportPublic FDA data

MAXAIR

Primary DI
00850078013064
Brand
MAXAIR
Company
Syntech, Int'l Inc.
Model
2085-03-IR
Catalog number
2085-03-IR
Device description
CAPR IR HELMET
Published
2026-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FXZHelmet, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXZHelmet, SurgicalGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040485000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040485000MAXAIR SURGICAL HELMET SYSTEMBio-Medical Devices, Inc.2004-10-18FYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850078013061PackageGS11In Commercial Distribution
00850078013064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085007801306110850078013061
00850078013064008500780130648500780130640850078013064

GMDN Terms#

Term, Definition table
TermDefinition
Surgical helmet systemA system intended for the purpose of protecting healthcare workers and patients from cross-infection during surgery. It is typically composed of a helmet frame with a face shield, a loose fitting disposable hood or gown draped around this, inflow and exhaust fans and filters, and a power supply, e.g., a battery pack to drive the internal ventilation.

Regulatory Flags#

DUNS number
078715452
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850078013026MAXAIR2084-04-PR2084-04-PR2026-04-24
00850078013033MAXAIR2500-36TSC-PR2500-36TSC-PR2026-04-24
00850078013040MAXAIR2500-37TSC-PR2500-37TSC-PR2026-04-24
00850078013071MAXAIR2600-02-PR2600-02-PR2026-04-24
00850078013002MAXAIR2281PRS-1002281PRS-1002026-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850078013026MAXAIRSyntech, Int'l Inc.FXZ2026-04-24
09009607811003ViVi® HELMET25THI Total Healthcare Innovation GmbHFXZ2025-11-10
09009607811010ViVi® HELMET25 XLTHI Total Healthcare Innovation GmbHFXZ2025-11-10
09009607811300ViVi® HELMET25 HPLTHI Total Healthcare Innovation GmbHFXZ2025-11-10
09009607811317ViVi® HELMET25 XL HPLTHI Total Healthcare Innovation GmbHFXZ2025-11-10
07613327625134Steri-ShieldSTRYKER CORPORATIONFXZ2025-02-26
07613327627039STERI-SHIELDSTRYKER CORPORATIONFXZ2025-02-26
07613327461312N/ASTRYKER CORPORATIONFXZ2020-08-06
07613327461336N/ASTRYKER CORPORATIONFXZ2020-08-06
00840277124159Innomed, Inc.INNOMED, INC.FXZ2020-05-18
04546540152558NASTRYKER CORPORATIONFXZ2018-09-24
04546540489579NASTRYKER CORPORATIONFXZ2018-09-24
04546540494153NASTRYKER CORPORATIONFXZ2018-09-24
04546540505019NASTRYKER CORPORATIONFXZ2018-09-24
04546540591579FlyteSTRYKER CORPORATIONFXZ2018-09-24
04546540591593FlyteSTRYKER CORPORATIONFXZ2018-09-24
04546540591609FlyteSTRYKER CORPORATIONFXZ2018-09-24
04546540591623FlyteSTRYKER CORPORATIONFXZ2018-09-24
04546540591630FlyteSTRYKER CORPORATIONFXZ2018-09-24
04546540591647FlyteSTRYKER CORPORATIONFXZ2018-09-24
04546540591654NASTRYKER CORPORATIONFXZ2018-09-24
04546540670069NASTRYKER CORPORATIONFXZ2018-09-24
04546540903839NASTRYKER CORPORATIONFXZ2018-09-24
04546540903877NASTRYKER CORPORATIONFXZ2018-09-24
07613154368167NASTRYKER CORPORATIONFXZ2018-09-24
07613154511105NASTRYKER CORPORATIONFXZ2018-09-24
07613154511198NASTRYKER CORPORATIONFXZ2018-09-24
07613154626366NASTRYKER CORPORATIONFXZ2018-09-24
07613154886289FlyteSTRYKER CORPORATIONFXZ2018-09-24
07613154891061FlyteSTRYKER CORPORATIONFXZ2018-09-24