FDA.reportPublic FDA data

SUMMIT MEDICAL

Primary DI
00385640054911
Brand
SUMMIT MEDICAL
Company
Summit Medical, Inc.
Model
LS7020
Published
2021-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10385640054918PackageGS110In Commercial Distribution
00859898006386PreviousGS10
00385640054911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038564005491810385640054918
00859898006386008598980063868598980063860859898006386
00385640054911003856400549113856400549110385640054911

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.

Regulatory Flags#

DUNS number
965484699
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00385640094689INSTRUSAFEIN-2020-82652026-10-01
00385640094696INSTRUSAFEIN-2020-81582026-10-01
00385640094702INSTRUSAFEIN-2020-81692026-10-01
00385640094719INSTRUSAFEIN-2020-82272026-10-01
00385640094658INSTRUSAFEIN-2020-77892026-09-30
00385640094665INSTRUSAFEIN-2020-72742026-09-30
00385640094672INSTRUSAFEIN-2020-82182026-09-30
00385640094580INSTRUSAFEIN-2020-81872026-09-29
00385640094597INSTRUSAFEIN-2020-76832026-09-29
00385640094603INSTRUSAFEIN-2020-82572026-09-29
00385640094610INSTRUSAFEIN-3030-03202026-09-29
00385640094627INSTRUSAFEIN-2020-82722026-09-29
00385640094634INSTRUSAFEIN-2020-82452026-09-29
00385640094641INSTRUSAFEIN-2020-82262026-09-29
00385640094566INSTRUSAFEIN-2020-81702026-09-28
00385640094573INSTRUSAFEIN-2020-82102026-09-28
00385640094535INSTRUSAFEIN-2020-77912026-09-24
00385640094542INSTRUSAFEIN-2020-77902026-09-24
00385640094559INSTRUSAFEIN-2020-81222026-09-24
00385640094511INSTRUSAFEIN-2020-81842026-09-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00749756402996DeRoyalDEROYAL INDUSTRIES, INC.KDQ2026-09-30
00749756403009DeRoyalDEROYAL INDUSTRIES, INC.KDQ2026-09-30
00749756403016DeRoyalDEROYAL INDUSTRIES, INC.KDQ2026-09-30
00749756403023DeRoyalDEROYAL INDUSTRIES, INC.KDQ2026-09-30
14026704911773PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-08-01
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00850040296464AOJShenzhen AOJ Health Science & Technology Co., Ltd.KDQ2026-07-11
00850079671102NavägeRhinosystems, Inc.KDQ2026-06-10
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
40884389968100MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
40884389968124MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
40888277143020MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
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40884389968070MEDLINEMEDLINE INDUSTRIES, INC.KDQ2025-11-28
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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