FDA.report

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
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KDQBottle, Collection, Vacuum

Product Code Classifications

CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06976358503880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06976358503880069763585038806976358503880

GMDN Terms

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

Regulatory Flags

DUNS number
847378548
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06976358502135SEPLOUURS30162025-09-17
06976358502142SEPLOUURS3016E2025-09-17
06976358502159SEPLOUURS30062025-09-17
06976358502166SEPLOUURS3006E2025-09-17
06976358502173SEPLOUURS30052025-09-17
06976358502180SEPLOUURS3005E2025-09-17
06976358503668SEPLOUSPAS10282025-09-17
06976358503675SEPLOUSPAS10352025-09-17
06976358503682SEPLOUSPAS10452025-09-17
06976358503699SEPLOUSPAS11352025-09-17
06976358503705SEPLOUSPAS11452025-09-17
06976358503712SEPLOUSPAS12352025-09-17
06976358503729SEPLOUSPAS12452025-09-17
06976358503736SEPLOUSPAS13352025-09-17
06976358503743SEPLOUSPAS13452025-09-17
06976358503750SEPLOUSPAS14352025-09-17
06976358503767SEPLOUSPAS14452025-09-17
06976358503774SEPLOUSPAS1033S2025-09-17
06976358503781SEPLOUSPAS1040S2025-09-17
06976358503798SEPLOUSPAS1050S2025-09-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850027043821Precision Medical Inc.Precision Medical, Inc.KDQ2026-02-25
00850027043838Precision Medical Inc.Precision Medical, Inc.KDQ2026-02-25
00650862199109AtriumAtrium Medical CorporationKDQ2026-02-10
20650862199158AtriumAtrium Medical CorporationKDQ2026-02-10
20650862199189AtriumAtrium Medical CorporationKDQ2026-02-10
06970462546849Stone CollectorShenzhen HugeMed Medical Technical Development Co., Ltd.KDQ2026-02-10
16970462546853Stone CollectorShenzhen HugeMed Medical Technical Development Co., Ltd.KDQ2026-02-10
10884389968109MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
10884389968123MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
10888277143029MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
10888277143517MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
00860014577536GROWNSYOak Tech LLCKDQ2026-01-28
00860014577543GROWNSYOak Tech LLCKDQ2026-01-28
00810477022272AMPLIMAMPLIM, LLCKDQ2026-01-16
00810477022289AMPLIMAMPLIM, LLCKDQ2026-01-16
00810116023769Dornier HOOVER Access SheathDORNIER MEDTECH AMERICA, INC.KDQ2026-01-14
00810116023752Dornier HOOVER Access SheathDORNIER MEDTECH AMERICA, INC.KDQ2026-01-14
10884389968079MEDLINEMEDLINE INDUSTRIES, INC.KDQ2025-11-28
34026704912194PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-09-17
10858276007707Polyp Trap single chamber bulkMicro-tech UsaKDQ2025-09-09
34026704911784PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-09-04
26944932721962Wellead Stone Collection BottleWell Lead Medical Co.,LtdKDQ2025-08-14
06944932726215Wellead Stone Collection BottleWell Lead Medical Co.,LtdKDQ2025-08-14
26944932726226Wellead Stone Collection BottleWell Lead Medical Co.,LtdKDQ2025-08-14
50749756394418DeRoyalDEROYAL INDUSTRIES, INC.KDQ2025-08-13
06976472080106Nasal aspiratorShenzhen Dongjiang Technology Co., Ltd.KDQ2025-07-25
06976472080113Nasal aspiratorShenzhen Dongjiang Technology Co., Ltd.KDQ2025-07-25
06976472080151Nasal aspiratorShenzhen Dongjiang Technology Co., Ltd.KDQ2025-07-25
06976472080168Nasal aspiratorShenzhen Dongjiang Technology Co., Ltd.KDQ2025-07-25
06976472080175Nasal aspiratorShenzhen Dongjiang Technology Co., Ltd.KDQ2025-07-25