FDA.reportPublic FDA data

DeVilbiss

Primary DI
00885304000884
Brand
DeVilbiss
Company
DEVILBISS HEALTHCARE LLC
Model
5650C
Catalog number
5650C
Device description
PULMO-AIDE CANADA
Published
2016-09-14
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
CAFNebulizer (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K923888000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K923888000DEVILBISS MODEL 5650 PULMO-AIDEDevilbiss Health Care, Inc.1993-02-23CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885304000884PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885304000884008853040008848853040008840885304000884

GMDN Terms#

Term, Definition table
TermDefinition
Medical device air compressorA mains electricity (AC-powered) device designed to create compressed air and supply it directly to gas-powered or compressed air dependent devices (e.g., ventilators or other respiratory devices, laboratory equipment). It may also provide medical air depending upon the filtering systems employed.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-338-1988somdhccustomerservice@devilbisshc.com

Regulatory Flags#

DUNS number
962175894
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885304034834DeVilbiss555DS555DS2026-05-12
00885304034841DeVilbiss555KS555KS2026-05-12
00885304034858DeVilbiss555PS555PS2026-05-12
00885304032045DeVilbiss125D-XB125D-XB2024-12-16
00885304033219DeVilbiss125D-BT 125D-BT 2025-04-28
00885304033226DeVilbiss125D-BT-XB125D-BT-XB2025-04-28
00885304033516DeVilbiss125D-ARYA-XB125D-ARYA-XB2025-04-28
00885304022237DeVilbiss125D125D2019-05-01
00885304033240DeVilbiss125D-BT-XB125D-BT-XB2025-04-28
00885304033257DeVilbiss125D-BT 125D-BT 2025-04-28
00885304000105DeVilbiss7310P-6037310P-6032024-11-08
00885304032557DeVilbiss7325D-D-EXF7325D-D-EXF2024-11-08
00885304032571DeVilbiss7325P-D-EXF7325P-D-EXF2024-11-08
00885304000907DeVilbiss5650I5650I2016-09-14
00885304000921DeVilbiss5650P5650P2016-09-14
00885304001676DeVilbiss3655PL-VA3655PL-VA2016-09-08
00885304022480DeVilbiss1025UK1025UK2017-08-17
00853040023382DeVilbiss7305D-D7305D-D2016-09-14
00885304000266DeVilbiss9352sr9352sr2016-09-24
00885304000327DeVilbiss7314P-D7314P-D2016-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719882305016MaxiNeb BANENCHANT TEK. CO, LTD.CAF2026-05-28
10304040194390Henry ScheinHENRY SCHEIN, INC.CAF2025-12-15
10197344012022HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344012541HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344011322HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-07-23
10197344137251HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-05-07
10197344137244HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-04-11
10197344006014HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-02-21
09420012463159Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAF2024-08-15
10197344077564HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-03-05
10193489138436HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138443HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138467HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138481HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10197344006021HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2023-12-15
10840330700426ProcureTwin Med, LLCCAF2022-11-03
10840330700433ProcureTwin Med, LLCCAF2022-11-03
10840330700440ProcureTwin Med, LLCCAF2022-11-03
10840330700457ProcureTwin Med, LLCCAF2022-11-03
10840330700464ProcureTwin Med, LLCCAF2022-11-03
10840330700471ProcureTwin Med, LLCCAF2022-11-03
10840330700488ProcureTwin Med, LLCCAF2022-11-03
10884389131657MedlineMEDLINE INDUSTRIES, INC.CAF2022-07-21
10193489016376MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10884389131640MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10190752141780AirLife™AIRLIFECAF2021-05-07
10190752160613AirLife™VYAIRE MEDICAL, INC.CAF2021-05-07
10190752160620AirLife™AIRLIFECAF2021-05-07
10190752148369AirLife™AIRLIFECAF2021-04-09
10190752114883AirLife™VYAIRE MEDICAL, INC.CAF2021-04-02