FDA.reportPublic FDA data

Bemis

Primary DI
10073088149548
Brand
Bemis
Company
Bemis de México, S.A. de C.V.
Model
3004
Catalog number
3004
Device description
3000CC QUICKFIT LINER 50 PACK INDIVIDUALLY BAGGED
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K771737000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K771737000SUCTION CANISTERBemis Health Care1977-12-20GCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10073088149548PrimaryGS10
00073088149541Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007308814954810073088149548
00073088149541000730881495410730881495410073088149541

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume3000Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP AWAY FROM SUNLIGHT

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
589153555
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10073088148855BEMIS108 040108 0402016-09-24
10073088149395BEMIS208 004208 0042016-09-24
10073088161854BEMIS175 030D175 030D2022-04-07
10073088148640BEMIS100 030 100 0302016-09-24
10073088148657BEMIS100 040100 0402016-09-24
10073088149272BEMIS175 020175 0202016-09-24
10073088149289BEMIS175 030175 0302016-09-24
10073088149296BEMIS175 040175 0402016-09-24
10073088149364BEMIS202 004202 0042016-09-24
10073088149371BEMIS202 040202 0402016-09-24
10073088149654BEMIS303 040303 0402016-09-24
10073088148763BEMIS102 030102 0302016-09-24
10073088148770BEMIS102 040102 0402016-09-24
10073088148848BEMIS108 030108 0302016-09-24
10073088149685BEMIS333 020333 0202016-09-24
10073088149692BEMIS333 030333 0302016-09-24
10073088149708BEMIS333 040333 0402016-09-24
10073088150704BEMIS208 040208 0402016-09-24
10073088149630BEMIS303 020303 0202016-09-24
10073088149647BEMIS303 030303 0302016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10198956241909CARDINAL HEALTHCardinal Health 200, LLCGCX2025-11-04
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08682952418014PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-13
10198956013704CARDINAL HEALTHCardinal Health 200, LLCGCX2025-05-09
08682952418144DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-08