FDA.reportPublic FDA data

De Soutter Medical

Primary DI
06970754496777
Brand
De Soutter Medical
Company
GCMEDICA ENTERPRISE LTD. (WUXI)
Model
GC1433C1U
Published
2022-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BYYTube, Aspirating, Flexible, Connecting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYYTube, Aspirating, Flexible, ConnectingGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970754494759PackageGS125In Commercial Distribution
06970754494766PackageGS110In Commercial Distribution
06970754496777PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970754494759069707544947596970754494759
06970754494766069707544947666970754494766
06970754496777069707544967776970754496777

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, single-useAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a single-use device.

Regulatory Flags#

DUNS number
527142751
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
06970754496159Orthopaedic Suction SetAEEFS11112023-09-08
16970754496156Orthopaedic Suction SetAEEFS11112023-09-08
16970754494862Dynarex CorporationGC1957R082023-02-04
36970754494866Dynarex CorporationGC1957R082023-02-04
06970754494728GcmedicaGC0652DD2022-12-09
06970754494735GcmedicaGC0653DD2022-12-09
06970754494742GcmedicaGC0654DT2022-12-09
06970754496593NatusGC8022F011420020,Adult,52CM*2+32CM,Clear2022-12-09
06970754496609NatusGC8022F011420050,Adult,52CM*2+2.15M,Clear2022-12-09
06970754496616NatusGC8022F121420030,Pediatric,52CM*2+92CM,Clear2022-12-09
06970754496623NatusGC8022F031420040,Infant,52CM*2+92CM,Clear2022-12-09
06970754498467GcmedicaGC0654DD2022-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150028399Liberant™EV3, INCBYY2026-05-07
00628725002224MED-RXCanadian Hospital Specialties LimitedBYY2025-04-25
00628725002231MED-RXCanadian Hospital Specialties LimitedBYY2025-04-25
10192253042894ArgyleCardinal Health 200, LLCBYY2025-02-27
10192253003222ArgyleCardinal Health 200, LLCBYY2024-09-27
50885380194519CARDINAL HEALTHCardinal Health 200, LLCBYY2024-09-18
14026704919410PILLINGTELEFLEX INCORPORATEDBYY2024-07-15
14026704919427PILLINGTELEFLEX INCORPORATEDBYY2024-07-15
14026704919434PILLINGTELEFLEX INCORPORATEDBYY2024-07-15
10840330704264ProCureTwin Med, LLCBYY2024-03-25
10840330704271ProCureTwin Med, LLCBYY2024-03-25
10840330704288ProCureTwin Med, LLCBYY2024-03-25
10840330704295ProCureTwin Med, LLCBYY2024-03-25
10840330704301ProCureTwin Med, LLCBYY2024-03-25
10840330704318ProCureTwin Med, LLCBYY2024-03-25
10840330704325ProCureTwin Med, LLCBYY2024-03-25
10840330704332ProCureTwin Med, LLCBYY2024-03-25
10840330704349ProCureTwin Med, LLCBYY2024-03-25
10850049784891SURGYCOSurgyco LLCBYY2023-10-31
10850049784907SURGYCOSurgyco LLCBYY2023-10-31
10653160360612MEDLINEMEDLINE INDUSTRIES, INC.BYY2023-05-29
B090ASP10390Control 10T Mechanical Thrombectomy FilterZIEN MEDICAL TECHNOLOGIES, INC.BYY2023-03-28
B090ASP10400Control 10T Mechanical Thrombectomy System Tubing, Female SuctionZIEN MEDICAL TECHNOLOGIES, INC.BYY2023-03-28
00749756376747DeRoyalDEROYAL INDUSTRIES, INC.BYY2023-02-02
00385640061629SUMMIT MEDICALSummit Medical, Inc.BYY2022-12-19
B090MT100Control 10T Mechanical Thrombectomy FilterZIEN MEDICAL TECHNOLOGIES, INC.BYY2022-10-24
B090MT1010030Control 10T Mechanical Thrombectomy System Tubing, 3-PackZIEN MEDICAL TECHNOLOGIES, INC.BYY2022-10-24
B090MT10100F0Control 10T Mechanical Thrombectomy System Tubing, Female SuctionZIEN MEDICAL TECHNOLOGIES, INC.BYY2022-10-24
20653405015106CONMEDConmed CorporationBYY2022-06-06
10080196035199MedlineMEDLINE INDUSTRIES, INC.BYY2022-04-15