FDA.reportPublic FDA data

n.a.

Primary DI
04048438006368
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
030647-10
Device description
Tubing Set, Suction, DS
Published
2020-01-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
04048438006368PrimaryGS10
04048438006344Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048438006368040484380063684048438006368
04048438006344040484380063444048438006344

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315731430
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048551001141n.a.495NCS2016-09-23
04048551004401n.a.495TIP2016-09-23
04048551004463n.a.50200FFL2018-08-21
04048551028568n.a.495ADM2016-09-23
04048551049549n.a.10970AE2018-08-17
04048551049563n.a.10970BE2018-08-17
04048551052495n.a.12016EM2016-09-23
04048551052525n.a.12016FM2016-09-23
04048551052990n.a.12061A2016-09-23
04048551053003n.a.12061AU2016-09-23
04048551053010n.a.12061AV2016-09-23
04048551053027n.a.12061AW2016-09-23
04048551053034n.a.12061AX2016-09-23
04048551053041n.a.12061B2016-09-23
04048551053065n.a.12061C2016-09-23
04048551053072n.a.12061F2016-09-23
04048551053089n.a.12061G2016-09-23
04048551053096n.a.12061H2016-09-23
04048551053102n.a.12061K2016-09-23
04048551082027n.a.233250B2016-09-23

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