FDA.reportPublic FDA data

DOUBLEFLO

Primary DI
03661379266045
Brand
DOUBLEFLO
Company
HEMODIA
Model
FC1
Catalog number
72205776
Device description
DOUBLEFLO INFLOW/OUTFLOW PUMP - Retrofit
Published
2025-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
03661379266045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661379266045036613792660453661379266045

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic irrigation/insufflation systemA mains electricity (AC-powered) device assembly designed to provide controlled distention and irrigation (expansion by pressure and continual flushing) of the tissue and space around a joint where arthroscopy is being performed (e.g., the knee or shoulder joint). This is achieved by filling the cavity with a sterile fluid that is pumped into the wound by the system's pump(s) and distends the tissue around the site to improve visualization and enlarge the surgical field. Suction may also be applied by the system to assist in the removal of the surgically-resected bone, cartilage, and other tissue/debris from the site.

Regulatory Flags#

DUNS number
381957786
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661379239056DOUBLEFLOB172205776F2023-09-29
03661379195994DOUBLEFLOA722053592022-08-29
03661379200414DOUBLEFLOA722053572022-08-29
03661379196007DOUBLEFOA722053602021-04-13
03661379196069DOUBLEFLOA722053662021-04-13
03661379196014DOUBLEFLOA722053612023-03-22
03661379196021DOUBLEFLOA722053622023-03-22
03661379196038DOUBLEFLOA722053632023-03-22
03661379196045DOUBLEFLOA722053642023-03-22
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

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Primary DI, Brand, Company table
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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
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07613327554649OmnicurveSTRYKER CORPORATIONHRX2023-11-02
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08800038056329SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31