FDA.reportPublic FDA data

BEMIS

Primary DI
10073088164244
Brand
BEMIS
Company
BEMIS MANUFACTURING COMPANY
Model
8002004L10
Catalog number
8002004L10
Device description
800CC HIFLOW SOLO SUCTION CANISTER WITH AEROSTAT FILTER, FLOAT VALVE SHUTOFF WITH WHITE LID
Published
2024-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
10073088164244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1007308816424410073088164244

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction system collection container, single-useA sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume800Milliliter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006072078
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10073088161755Bemis7209824-J7209824-J2021-06-17
10073088165296BemisPAL-SC-3000PAL-SC-30002025-02-07
10073088165302BEMISPAL-SC-2000PAL-SC-20002025-02-07
00073088165299BemisPAL-SC-3000PAL-SC-30002025-02-07
00073088165305BEMISPAL-SC-2000PAL-SC-20002025-02-07
10073088150414Bemis5350105350102016-09-24
10073088150490Bemis5384105384102016-09-24
10073088162660BEMIS6354106354102024-11-25
00073088162663BEMIS6354106354102024-11-25
10073088162646BEMIS6244106244102024-10-23
00073088162649BEMIS6244106244102024-10-23
10073088162653BEMIS6344106344102024-10-15
10073088162677BEMIS6364106364102024-10-15
00073088162656BEMIS6344106344102024-10-15
00073088162670BEMIS6364106364102024-10-15
20073088150565BEMIS8002 055 N8002 055 N 2024-10-15
10073088150421Bemis5355105355102016-09-24
10073088150476Bemis5381105381102016-09-24
10073088150483Bemis5382105382102016-09-24
20073088149842Bemis424410 10424410 102016-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704937247PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
14026704937254PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
14026704937261PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
14026704937278PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
14026704937285PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
14026704937292PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
14026704937353PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
00628725095363Pleural Drain Dry Seal System CHS USA Inc.KDQ2026-04-17
00628725095370Pleural Drain Wet Seal System CHS USA Inc.KDQ2026-04-17
40884389968100MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
40884389968124MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
40888277143020MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
40888277143518MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
40884389968070MEDLINEMEDLINE INDUSTRIES, INC.KDQ2025-11-28
14026704912190PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-09-17
14026704911780PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-09-04
14026704911902PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-07-02
14026704911872PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911889PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911896PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911919PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911926PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911933PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911940PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
10192253002652Thora-SealCardinal Health 200, LLCKDQ2025-02-19
10192253002645Thora-SealCardinal Health 200, LLCKDQ2025-02-18
10192253002669Thora-SealCardinal Health 200, LLCKDQ2025-02-18
10192253002676ArgyleCardinal Health 200, LLCKDQ2025-02-18
10073088165296BemisBEMIS MANUFACTURING COMPANYKDQ2025-02-07
10073088165302BEMISBEMIS MANUFACTURING COMPANYKDQ2025-02-07