FDA.reportPublic FDA data

BiTrac

Primary DI
00841470105563
Brand
BiTrac
Company
PULMODYNE INC
Model
10160051
Published
2025-04-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
K023683000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023683000MULTI-STRAP FULL FACE MASKEngineered Medical Systems2003-12-01BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841470105560PackageGS110In Commercial Distribution
00841470105563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084147010556010841470105560
00841470105563008414701055638414701055630841470105563

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP face mask, single-useA non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
030619483
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841470100841Percussor313-41962026-05-29
00841470100858Percussor313-41972026-05-29
00841470104740BiTrac Select313-95892025-09-30
00841470104764BiTrac Select313-95912025-09-30
00841470100148O2-MAX313-8201-62025-04-12
00841470105501BiTrac101615782025-04-11
00841470105518BiTrac 101615772025-04-11
00841470105525BiTrac101615792025-04-11
00841470105532BiTrac101615762025-04-11
00841470105549BiTrac 101600492025-04-11
00841470105556BiTrac 101600502025-04-11
00841470105570BiTrac 101600522025-04-11
00841470105587BiTrac SE101600532025-04-11
00841470105594BiTrac SE101600542025-04-11
00841470105600BiTrac SE101600552025-04-11
00841470105617BiTrac SE101600562025-04-11
00841470105631BiTrac Select101617662025-04-11
00841470105648BiTrac Select101617672025-04-11
00841470105655BiTrac Select101617682025-04-11
00841470105662BiTrac SE Select 101617692025-04-11

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