FDA.reportPublic FDA data

GENTEC®

Primary DI
06970966663110
Brand
GENTEC®
Company
GENTEC(SHANGHAI)CORPORATION
Model
SJ-1500
Device description
SJ-1500 is the suction jar which is used to collect pus, blood clots, phlegm, and excess fluids by connecting to a patient on one end, and vacuum source (such as suction regulator) on the other
Published
2021-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
06970966663110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970966663110069709666631106970966663110

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction system collection container, reusableA 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., 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 reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
545287658
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970966665220GENTEC®34U-OXY2023-08-01
06970966665886GENTEC®O-W200-F70-GS2023-08-01
06970966665893GENTEC®O-W200-F70-BS2023-08-01
06970966665909GENTEC®O-G200-F70-DS2023-08-01
06970966665916GENTEC®O-W200-F70-DS2023-08-01
06970966663936GENTEC®O-W200-F70 Series2023-07-05
06970966663721GENTEC®34I-OXY Series2023-06-21
06970966663776GENTEC®35I-OXY Series2023-06-21
06970966663820GENTEC®34U-OXY Series2023-06-21
06970966663875GENTEC®35U-OXY Series2023-06-21
06970966663929GENTEC®FM197A -70L-HS Series2023-06-21
06970966669167GENTEC®FMD197A Series2024-11-16
06970966669068GENTEC®FM-PTO2024-08-05
06970966669037GENTEC®Y-VAC-CPLR-OH2024-07-26
06970966669044GENTEC®Y-VAC-CPLR-DH2024-07-26
06970966669051GENTEC®Y-OXY-CPLR-OH2024-07-26
06970966666753GENTEC®195M-950D2024-06-28
06970966666371GENTEC® GMX30E-AIR/O2-DS-P152024-03-25
06970966666357GENTEC®882VR-200-00-T2023-12-26
06970966666340GENTEC®882VR-200-DS-T-1.5L2023-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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