FDA.reportPublic FDA data

DOUBLEFLO

Primary DI
23661379195509
Brand
DOUBLEFLO
Company
HEMODIA
Model
A
Catalog number
72205354
Device description
DOUBLEFLO PATIENT 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
OTC
false
Sterile
true
Single use
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
03661379195505PrimaryGS10
23661379195509Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661379195505036613791955053661379195505
2366137919550923661379195509

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
381957786
Device count
40
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCHRX2026-06-03
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