FDA.reportPublic FDA data

VersaPAP™ Positive Airway Pressure Device

Primary DI
62860121501035
Brand
VersaPAP™ Positive Airway Pressure Device
Company
Trudell Medical International
Model
121501
Catalog number
12150194100
Device description
VersaPAP™ Positive Airway Pressure Device
Published
2019-03-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BWFSpirometer, Therapeutic (Incentive)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWFSpirometer, Therapeutic (Incentive)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173918000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173918000VersaPAP Positive Airway Pressure (PAP) DeviceTrudell Medical International2018-08-17BWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
62860121501035PrimaryGS10
62860121501011Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6286012150103562860121501035
6286012150101162860121501011

GMDN Terms#

Term, Definition table
TermDefinition
In-line CPAP set, non-nebulizingA portable collection of devices intended to be connected to a medical gas supply to assist non-intubated ventilation (i.e., without an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous patient respiration in respiratory emergency situations and/or respiratory therapy settings. It includes an in-line/gas-line CPAP device (a small plastic unit intended to establish a gas pressure proportional to gas flow rate), a mouthpiece or face mask, and may include additional components (e.g., tubing, manometer gauge); it does not include a nebulizer. This is a single-patient, reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-519-455-4862customerservice@trudellmed.com

Regulatory Flags#

DUNS number
203298203
Device count
100
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00762860000582OMBRA* Table Top Compressor System 105510105510940062025-11-06
00762860055100OMBRA 120V Table Top Compressor System1055102020-03-25
62860105509026AEROECLIPSE BAN Replacement Mouthpiece Assembly105509105509940802020-03-24
62860105501020AEROECLIPSE II Breath Actuated Nebulizer Disposable105501105501940502016-09-24
62860105505028AEROECLIPSE II Breath Actuated Nebulizer Disposable with Elbow Adapter105505105505940502016-09-24
62860105506025AEROECLIPSE II Elbow Adapter for Breath Actuated Nebulizer Disposable105506105506940502016-09-24
62860105507022AEROECLIPSE XL Reusable Breath Actuated Nebulizer w AeroControl System Regulator105507105507940102016-09-24
62860105513016AeroEclipse* XL Breath Actuated Nebulizer105513105510940062016-09-24
62860105514020EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN105514105514940102016-09-30
62860105541026AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing105541105541940502016-09-24
62860105542023AEROECLIPSE II Breath Actuated Nebulizer without Oxygen Tubing105542105542940502016-09-24
00762860001138RESPICHAMBER* VHC with Mouthpiece1015332024-03-11
00762860055025REUSABLE COMFORTSEAL® Silicone Mask Assembly1055022024-03-11
00762860055032REUSABLE COMFORTSEAL® Silicone Mask Assembly1055032024-03-11
00762860055049REUSABLE COMFORTSEAL® Silicone Mask Assembly1055042024-03-11
10762860001135RESPICHAMBER* VHC with Mouthpiece1015332024-03-11
10762860055022REUSABLE COMFORTSEAL® Silicone Mask Assembly1055022024-03-11
10762860055039REUSABLE COMFORTSEAL® Silicone Mask Assembly1055032024-03-11
10762860055046REUSABLE COMFORTSEAL® Silicone Mask Assembly1055042024-03-11
00762860000827AEROCHAMBER* MV Holding Chamber825918251100502023-12-01

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