FDA.reportPublic FDA data

DOUBLEFLO

Primary DI
03661379195499
Brand
DOUBLEFLO
Company
HEMODIA
Model
A
Catalog number
72205353
Device description
DOUBLEFLO DAY TUBE SET
Published
2021-04-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203480000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203480000DOUBLEFLO systemHemodia Sas2021-04-05HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661379195499PrimaryGS10
23661379195493Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661379195499036613791954993661379195499
2366137919549323661379195493

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration tubing setA collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Regulatory Flags#

DUNS number
381957786
Device count
30
Lot or batch
true
Manufacturing date on label
true
Expiration 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
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

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Primary DI, Brand, Company table
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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
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08809281659370BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
07613327601695Connected OR HubSTRYKER CORPORATIONHRX2025-06-04
07613327601701SDC4K Information Management SystemSTRYKER CORPORATIONHRX2025-06-04
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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
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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