FDA.reportPublic FDA data

Suction bag, single packed, 3000 ml

Primary DI
06418685063014
Brand
Suction bag, single packed, 3000 ml
Company
Serres Oy
Model
570187-2
Published
2018-02-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KDQBottle, Collection, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06418685063014PackageGS1160In Commercial Distribution
06418685062994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06418685063014064186850630146418685063014
06418685062994064186850629946418685062994

GMDN Terms#

Term, Definition table
TermDefinition
Suction system canister linerA device made of disposable materials used to cover the inner surface of a suction system reusable canister, for the collection of substances such as blood, bodily fluids, rinsing fluids, body tissue, or gas (e.g., laser plume evacuation) from a site of operation. The device may be soft-walled, or it may have walls of semi-rigid plastic with a dedicated lid. Together with the canister, it can be used singularly, or in a connected series to provide greater capacity. This device should be discarded, including its contaminated waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
401738638
Device count
1
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06418685061942Suction bag with dual filter, 2000ml570167-52018-02-05
06418685061973Suction bag with dual filter, 3000ml570187-52018-02-05
06418685048219Measuring cup 250 ml5702572018-02-05
06418685048608Suction canister, 1000 ml5703082018-02-05
06418685048707Suction canister, 2000 ml5703282018-02-05
06418685048806Suction canister, 3000 ml5703482018-02-05
06418685048905Suction canister blue, 1000 ml5703092018-02-05
06418685049001Suction canister blue, 2000 ml5703292018-02-05
06418685013408Suction bag for Laerdal LSU pump - single-packed 1000 ml571512018-02-05
06418685020918Suction bag for Laerdal LSU pump, 1000 ml57151-22018-02-05
06418685048226Measuring cup 250 ml5702572018-02-05
06418685048622Suction canister, 1000 ml5703082018-02-05
06418685048721Suction canister, 2000 ml5703282018-02-05
06418685048820Suction canister, 3000 ml5703482018-02-05
06418685048929Suction canister blue, 1000 ml5703092018-02-05
06418685049025Suction canister blue, 2000 ml5703292018-02-05
06418685047014Pre-gelled bag, folded, 2000 ml570567-02018-02-05
06418685047410Suction bag, folded, 2000 ml570167-02018-02-05
06418685047519Suction bag, folded, 3000 ml570187-02018-02-05
06418685047618Pre-gelled bag, 1000 ml 5705572018-02-05

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