FDA.reportPublic FDA data

DOUBLEFLO

Primary DI
03661379196045
Brand
DOUBLEFLO
Company
HEMODIA
Model
A
Catalog number
72205364
Device description
HAND CONTROL INTERFACE CMD
Published
2023-03-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221919000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221919000DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing setsHemodia Sas2023-03-09HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661379196045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661379196045036613791960453661379196045

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
381957786
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661379266045DOUBLEFLOFC1722057762025-10-06
03661379239056DOUBLEFLOB172205776F2023-09-29
03661379195994DOUBLEFLOA722053592022-08-29
03661379200414DOUBLEFLOA722053572022-08-29
03661379196007DOUBLEFOA722053602021-04-13
03661379196069DOUBLEFLOA722053662021-04-13
03661379196014DOUBLEFLOA722053612023-03-22
03661379196021DOUBLEFLOA722053622023-03-22
03661379196038DOUBLEFLOA722053632023-03-22
03661379196052DOUBLEFLOA722053652023-03-22
03661379196076DOUBLEFLOA722053672023-03-22
03661379196083DOUBLEFLOA722053682023-03-22
03661379196090DOUBLEFLOA722053692023-03-22
03661379196113DOUBLEFLOA722053712023-03-22
03661379223055DOUBLEFLOA722057722023-01-25
23661379223059DOUBLEFLOA722057722023-01-25
03661379223062DOUBLEFLOA722057732023-01-25
03661379223079DOUBLEFLOA722057742023-01-25
03661379223086DOUBLEFLOA722057652023-01-25
03661379211748DOUBLEFLOB1722057762023-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCHRX2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCHRX2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCHRX2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCHRX2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCHRX2026-06-03
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-02
00846338005146Neutral PlateELLIQUENCE, LLCHRX2026-06-01
00846338005320Needle PunchELLIQUENCE, LLCHRX2026-06-01
08809281659387BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2026-05-11
08809281659301BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
08809281659325BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
08809281659370BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
07613327601695Connected OR HubSTRYKER CORPORATIONHRX2025-06-04
07613327601701SDC4K Information Management SystemSTRYKER CORPORATIONHRX2025-06-04
07613327638448OmnicurveSTRYKER CORPORATIONHRX2024-09-03
08800038059313SYNTH™ STANDARDIMEDICOM CO., LTD.HRX2024-03-25
08800038058187SYNTH™ PLUSIMEDICOM CO., LTD.HRX2024-03-22
08800038058200SYNTH™ PLUSIMEDICOM CO., LTD.HRX2024-03-22
08800038057906MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057913MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057920MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057937MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057944MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
07613327554649OmnicurveSTRYKER CORPORATIONHRX2023-11-02
08800038056305SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056312SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056329SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31