FDA.reportPublic FDA data

McKesson

Primary DI
10612479216904
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-3665LT
Device description
Compressor Nebulizer System
Published
2017-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BTICompressor, Air, Portable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTICompressor, Air, PortableAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031413000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031413000VIGORMIST COMPRESSOR NEBULIZERVega Technologies, Inc.2003-10-07BTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20612479216918PackageGS11In Commercial Distribution
40612479216929PackageGS14In Commercial Distribution
10612479216904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2061247921691820612479216918
4061247921692940612479216929
1061247921690410612479216904

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
Device count
1
Lot or batch
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00612479151291McKesson16-DEN-12026-07-09
00612479274648McKesson48392025-01-17
20612479285723McKessonGCCOV-502a-MB2026-06-18
20612479285747McKessonCCOVAg-PNMB2026-06-18
00612479271050McKesson16-L2NWT6Y-XL2024-04-17
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344214723MEDLINEMEDLINE INDUSTRIES, INC.BTI2026-07-13
00810050863438MedPakLIFEPORT, LLCBTI2026-05-06
00038214001773Pulmo-Mist CompressorNIDEK MEDICAL PRODUCTS, INC.BTI2026-04-20
00038214001780Pulmo-Mist Compressor NIDEK MEDICAL PRODUCTS, INC.BTI2026-04-20
00038214001797Pulmo-Mist Compressor NIDEK MEDICAL PRODUCTS, INC.BTI2026-04-20
00762860000582OMBRA* Table Top Compressor System Trudell Medical InternationalBTI2025-11-06
10197344149070MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344149087MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344149094MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344149100MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344135592MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-14
10197344135585MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344154180MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344154197MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344154203MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344135578MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-07-28
00197344042817MedlineMEDLINE INDUSTRIES, INC.BTI2024-02-16
00810050862745Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2024-01-11
00810050862707Utility Pedestal AssemblyLIFEPORT, LLCBTI2023-12-15
00810050862691Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-12-08
00810050862677Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-11-10
00810050862615Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-10-23
00810050862622Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-10-23
00810050862523Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-08-23
00810050862530Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-08-23
00810050862547Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-08-23
00810050862431Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-06-06
00810050862363Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-03-16
00810050862370Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-03-16
00810050862325Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-02-07