FDA.reportPublic FDA data

SEPLOU

Primary DI
06976358503880
Brand
SEPLOU
Company
SEPLOU (ZHUHAI) CO.,LTD.
Model
SPCB1160
Published
2025-09-17
Public version status
New
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
06976358503880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976358503880069763585038806976358503880

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
847378548
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
06976358502845SEPLOUSPRB11132026-05-14
06976358502852SEPLOUSPRB11152026-05-14
06976358502869SEPLOUSPRB11172026-05-14
06976358502876SEPLOUSPRB11182026-05-14
06976358502883SEPLOUSPRB11192026-05-14
06976358502890SEPLOUSPRB11222026-05-14
06976358502906SEPLOUSPRB22302026-05-14
06976358502913SEPLOUSPRB13152026-05-14
06976358502920SEPLOUSPRB13172026-05-14
06976358502937SEPLOUSPRB13182026-05-14
06976358502944SEPLOUSPRB13192026-05-14
06976358502951SEPLOUSPRB1113Z2026-05-14
06976358502968SEPLOUSPRB1115Z2026-05-14
06976358502975SEPLOUSPRB1117Z2026-05-14
06976358502982SEPLOUSPRB1118Z2026-05-14
06976358502999SEPLOUSPRB1119Z2026-05-14
06976358503002SEPLOUSPRB1122Z2026-05-14
06976358503019SEPLOUSPRB2230Z2026-05-14
06976358503026SEPLOUSPRB1315Z2026-05-14
06976358503033SEPLOUSPRB1317Z2026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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