FDA.reportPublic FDA data

DK50 DS

Primary DI
08586014620646
Brand
DK50 DS
Company
EKOM spol. s r.o.
Model
BAS KOL 115V/60Hz 3bar NO
Published
2016-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K091871000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091871000DK50 DSEkom S.R.O.2009-10-23BTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08586014620646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08586014620646085860146206468586014620646

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.

Regulatory Flags#

DUNS number
360551766
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08586014620059E190-100V/50-60 Hz2016-05-13
08586014620066E1110-120V/60-50Hz2016-05-13
08586014620073E1220-240V/50-60Hz2016-05-13
08586014620301MC40 C 230V/50Hz KAR2016-05-26
08586014625047DK50 DSBAS NOZ 115V 60Hz 3bar NO MEK2023-06-14
08586014620295MC40 230V/50Hz KARTON2016-05-26
08586014620905DK50 DM230V/50Hz NO2016-09-27
08586014620912DK50 D230V/50Hz-SOFT-M.O.2016-09-27
08586014621407DK50 DS120V/60Hz UL 3bar NO 2022-10-12
08586014621131Air-550120V 60Hz2020-03-31
08586014621414Air-550230V 50/60Hz2020-03-31
08586014620127C235C2352016-05-13
08586014620134C235C2352016-05-13
08586014620141C235C2352016-05-13
08586014620158C235C2352016-05-13
08586014620165C235C2352016-05-13
08586014620639DK50 DS BAS NOZ 115V/60Hz 3bar NO2016-05-26
08586014620653DK50 DS BAS SD30E 115V/60Hz 3bar NO2016-05-26
08586014620660DK50 DS STA KOL 115V/60Hz 3bar NO2016-05-26
08586014620677DK50 DS STA NOZ 115V/60Hz 3bar NO2016-05-26

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Primary DI, Brand, Company table
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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
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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
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00810050862523Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-08-23
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00810050862325Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-02-07
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