FDA.reportPublic FDA data

DeVilbiss

Primary DI
00885304000280
Brand
DeVilbiss
Company
Drive Devilbiss Healthcare
Model
9354DR
Device description
Respiratory Nebs Product Description FlexSet Cmft Tch Sil Msk size M
Published
2020-04-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112220000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112220000DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVELDevilbiss Healthcare, LLC2011-11-22BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885304000280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885304000280008853040002808853040002800885304000280

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator IMV controllerAn unit that, added to a ventilator otherwise incapable of providing intermittent mandatory ventilation (IMV) or synchronized intermittent mandatory ventilation (SIMV) functions, permits the ventilator to provide this kind of breathing mode to the patient during his/her attempts at spontaneous breathing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
867673159
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00822383037127Silver SportBIN-SSP316DDA-SF2026-06-22
00822383037134Silver SportBIN-SSP218DDA-SF2026-06-22
00822383037141Silver SportBIN-SSP220DDA-SF2026-06-22
00822383037158Cruiser 3 16"BIN-K316ADDA-SF2026-06-22
00822383037165Cruiser 3 18"BIN-K318ADDA-SF2026-06-22
00822383037172Cruiser 3 20"BIN-K320ADDA-SF2026-06-22
00194346283439EquateEQKW5002026-06-10
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20
00023601005168CAREX HEALTH BRANDSFGA51600 GRN2022-12-20
00023601005175CAREX HEALTH BRANDSFGA51700 BRNZ2022-12-20
00023601005182CAREX HEALTH BRANDSFGA51800 GRAY2022-12-20
00023601007117CAREX HEALTH BRANDSFGA71100 00002023-03-15
00023601007179CAREX HEALTH BRANDSFGA71700 00002023-03-15
00023601007186CAREX HEALTH BRANDSFGA71800 00002023-03-15
00023601007193CAREX HEALTH BRANDSFGA71900 00002023-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850088881035IBEETShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881042IBEETShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881059MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881066MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881028ItAllShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-09
00198843003347Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003361Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003385Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003408Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003422Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003545Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003552Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003569Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003576Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003583Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003590Infant Flow™Zoll Medical CorporationBZD2026-06-24
00814747024935MiniMe 2 Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024942MiniMe 2 Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747024959MiniMe 2 Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024966MiniMe 2 Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747024973Novaplus Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024980Novaplus Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024997Novaplus Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747025000Novaplus Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
04048675824121Seattle PAPDrägerwerk AG & Co. KGaABZD2026-06-11
00848530108984CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530108991CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109004CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109042CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109059CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04