FDA.reportPublic FDA data

DISPOSABLE HVAC / HVE SCREENS

Primary DI
D89260705531320
Brand
DISPOSABLE HVAC / HVE SCREENS
Company
MAXILL, INC.
Model
6070553132
Published
2022-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DZNInstruments, Dental Hand

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D89260705531321PrimaryHIBCC0
D89260705531320Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit condensate trap, single-useA non-sterile device intended to be integrated within a breathing circuit (e.g., ventilator or respirator breathing circuit) to collect the condensate which accumulates typically during heated humidification. It includes a fluid collection container with input and output connections, and may have an automatic seal to prevent fluid leaks when removed from the circuit; it does not include a moisture filter. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079343581
Device count
144
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
D89260705600570AUTOCLAVE TAPE60705600572022-09-19
D89260705600580AUTOCLAVE TAPE60705600582022-09-19
D89260705600590AUTOCLAVE TAPE60705600592022-09-19
00060705811240u-test SI Steam Sterilization Integrator811242016-10-17
D89260705533181POLYALL CURING LIGHT SLEEVE60705533182022-07-22
D89260705533182POLYALL CURING LIGHT SLEEVE60705533182022-07-22
D89260705533191POLYALL CURING LIGHT SLEEVE60705533192022-07-22
D89260705533192POLYALL CURING LIGHT SLEEVE60705533192022-07-22
D89260705535201COVERMAX OPTIMUM HEADREST COVER60705535202022-10-20
D8926070553525BU1COVERMAX OPTIMUM HEADREST COVER6070553525BU2022-10-20
D8926070553525GN1COVERMAX OPTIMUM HEADREST COVER6070553525GN2022-10-20
D8926070553525LV1COVERMAX OPTIMUM HEADREST COVER6070553525LV2022-10-20
D89260705533601PHOSPHOR PLATE BARRIER ENVELOPES60705533602022-07-22
D89260705533602PHOSPHOR PLATE BARRIER ENVELOPES60705533602022-07-22
D89260705533611PHOSPHOR PLATE BARRIER ENVELOPES60705533612022-07-22
D89260705533612PHOSPHOR PLATE BARRIER ENVELOPES60705533612022-07-22
D89260705533621PHOSPHOR PLATE BARRIER ENVELOPES60705533622022-07-22
D89260705533622PHOSPHOR PLATE BARRIER ENVELOPES60705533622022-07-22
D89260705533651PHOSPHOR PLATE BARRIER ENVELOPES60705533652022-07-22
D89260705533652PHOSPHOR PLATE BARRIER ENVELOPES60705533652022-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB7500TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7510TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7520TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7530TBS BASICSACME ENTERPRISE.DZN2026-05-21
08404535018929Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535018950Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019049Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019070Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019131Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019162Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
07908854000647Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000654Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000661Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000678Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000838Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000883Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000890Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001040Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001071Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001163Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001170Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001354Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001460Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001477Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001484Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001491Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001507Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001514Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001521Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001538Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22