FDA.reportPublic FDA data

SUMMIT MEDICAL

Primary DI
00385640067959
Brand
SUMMIT MEDICAL
Company
Summit Medical, Inc.
Model
LSCONNECT
Published
2021-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K854359000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K854359000LM2000A SURGICAL SUCTION MONITOREngineering, Inc.1986-03-03KDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00385640067959PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385640067959003856400679593856400679590385640067959

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical suction system, vacuumAn assembly of vacuum-powered devices, which includes a surgically invasive component, designed to aspirate unwanted materials (e.g., debris, tissues, fluids) from body cavities/wounds during a surgical procedure (e.g., general surgery, laparoscopy); it may in addition have non-surgical applications. It is connected via dedicated tubing to the terminal unit (wall outlet) of a vacuum pipeline system and relies on the healthcare facility’s central vacuum system. It includes a vacuum suction regulator which controls negative pressure for the aspiration, collection containers, and patient contact devices (e.g., handpiece/tip); it typically also includes tubing and microbial/hydrophobic filters.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
965484699
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00385640095174INSTRUSAFEIN-2020-80252026-10-20
00385640095181INSTRUSAFEIN-2020-82952026-10-20
00385640095198INSTRUSAFEIN-2020-82282026-10-20
00385640095204INSTRUSAFEIN-2020-82732026-10-20
00385640095167INSTRUSAFEIN-2020-77352026-10-16
00385640095082INSTRUSAFEIN-2020-82852026-10-15
00385640095099INSTRUSAFEIN-2020-81252026-10-15
00385640095105INSTRUSAFEIN-2020-82152026-10-15
00385640095112INSTRUSAFEIN-2020-79102026-10-15
00385640095129INSTRUSAFEIN-2020-82582026-10-15
00385640095136INSTRUSAFEIN-2020-80112026-10-15
00385640095143INSTRUSAFEIN-2300-05-EN-1522026-10-15
00385640095150INSTRUSAFEIN-2300-05-EN-1532026-10-15
00385640095051INSTRUSAFEIN-2020-81722026-10-14
00385640095068INSTRUSAFEIN-2020-82842026-10-14
00385640095075INSTRUSAFEIN-2020-81232026-10-14
00385640095044INSTRUSAFEIN-2020-82382026-10-13
00385640094887INSTRUSAFEIN-2020-81602026-10-09
00385640094894INSTRUSAFEIN-2020-74472026-10-09
00385640094870INSTRUSAFEIN-2020-81062026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344219254MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-10-16
00749756402989DeRoyalDEROYAL INDUSTRIES, INC.KDQ2026-09-30
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
04719874957476Create BiotechCREATE BIOTECH CO., LTD.KDQ2026-07-21
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
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
06936603230008SafeSnapYangzhou Fartley Medical Instrument Technology Co., LtdKDQ2025-06-13
06936603230022SafeSnapYangzhou Fartley Medical Instrument Technology Co., LtdKDQ2025-06-13
14026704911872PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911889PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911896PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12