FDA.reportPublic FDA data

MAXAIR

Primary DI
00850078013125
Brand
MAXAIR
Company
Syntech, Int'l Inc.
Model
2600-04-IR
Catalog number
2600-04-IR
Device description
CHARGER
Published
2026-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, 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
10850078013122PackageGS11In Commercial Distribution
00850078013125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085007801312210850078013122
00850078013125008500780131258500780131250850078013125

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
DM exempt
false
Premarket exempt
false
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
00850078013101MAXAIR2500-26-IR2500-26-IR2026-08-26
00850078013118MAXAIR2600-03-IR2600-03-IR2026-08-26
00850078013132MAXAIR2500-27-IR2500-27-IR2026-08-26
00850078013149MAXAIR2600-04A-IR2600-04A-IR2026-08-26
00850078013026MAXAIR2084-04-PR2084-04-PR2026-04-24
00850078013033MAXAIR2500-36TSC-PR2500-36TSC-PR2026-04-24
00850078013040MAXAIR2500-37TSC-PR2500-37TSC-PR2026-04-24
00850078013064MAXAIR2085-03-IR2085-03-IR2026-04-24
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
00850078013101MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013118MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013132MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013149MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00840456224571JMUJMU DENTAL, INCLYU2026-08-18
00840456224588JMUJMU DENTAL, INCLYU2026-08-18
00840456224595JMUJMU DENTAL, INCLYU2026-08-18
00840456224601JMUJMU DENTAL, INCLYU2026-08-18
00840456224618JMUJMU DENTAL, INCLYU2026-08-18
00840456218402JMUJMU DENTAL, INCLYU2026-07-06
00840456218419JMUJMU DENTAL, INCLYU2026-07-06
00840456218426JMUJMU DENTAL, INCLYU2026-07-06
00840456218433JMUJMU DENTAL, INCLYU2026-07-06
00840456218440JMUJMU DENTAL, INCLYU2026-07-06
00840456218457JMUJMU DENTAL, INCLYU2026-07-06
00840456218464JMUJMU DENTAL, INCLYU2026-07-06
00840456218471JMUJMU DENTAL, INCLYU2026-07-06
00840456218488JMUJMU DENTAL, INCLYU2026-07-06
00840456218495JMUJMU DENTAL, INCLYU2026-07-06
00840456220894JMUJMU DENTAL, INCLYU2026-07-06
00840456220900JMUJMU DENTAL, INCLYU2026-07-06
00840456220917JMUJMU DENTAL, INCLYU2026-07-06
00840456220924JMUJMU DENTAL, INCLYU2026-07-06
00840456220931JMUJMU DENTAL, INCLYU2026-07-06
00840456220948JMUJMU DENTAL, INCLYU2026-07-06
00840456220955JMUJMU DENTAL, INCLYU2026-07-06
00840456220962JMUJMU DENTAL, INCLYU2026-07-06
00840456220979JMUJMU DENTAL, INCLYU2026-07-06
00840456220986JMUJMU DENTAL, INCLYU2026-07-06
00840456224328JMUJMU DENTAL, INCLYU2026-07-06