FDA.reportPublic FDA data

SCOPE BUDDY PLUS TUBING

Primary DI
00677964082948
Brand
SCOPE BUDDY PLUS TUBING
Company
MEDIVATORS INC.
Model
SB-110-HU1009
Catalog number
SB110HU1009
Device description
Scope Buddy Plus Tubing, Fujifilm
Published
2019-06-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FEBAccessories, Cleaning, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEBAccessories, Cleaning, For EndoscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162128000
K213833000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162128000Scope Buddy Plus Endoscope Flushing AidMedivators, Inc.2016-12-21FEB
K213833000SCOPE BUDDY PLUS Endoscope Flushing AidMedivators, Inc.2022-01-14FEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10677964082945PackageGS130In Commercial Distribution
20677964082942PackageGS130In Commercial Distribution
00677964082948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1067796408294510677964082945
2067796408294220677964082942
00677964082948006779640829486779640829480677964082948

GMDN Terms#

Term, Definition table
TermDefinition
Luer/non-ISO80369-standardized linear connector, reusableA small, non-powered, noninvasive tubular device with a Luer connection (either lock or slip) at one end and a connection which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases) at the other end (typically barbed, conical, threaded or non-Luer-slip) intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
068199363
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00677964021695CER-1CER-178399-7232016-09-20
00677964033858DSD-201DSD-201 120VDSD20172016-09-20
00677964035647SSD-102SSD-102SSD20072016-09-20
00677964044755Advantage Plus Endoscope Reprocessing System1-2-510.0032016-09-16
00677964046674DSD Edge Endoscope Reprocessing SystemDSD Edge 120VDSD30082016-09-16
00677964052484CER-1 OptimaCER-1 OptimaCER1OPTIMA2016-09-20
00677964052491CER-2 OptimaCER-2 OptimaCER2OPTIMA2016-09-20
00677964095832Advantage Plus Pass-Thru1-2-610.003126100032018-02-06
00677964153877Endo Carry-on Procedure Kit401137340113732026-07-20
00677964153921Endo Carry-on Procedure Kit401139040113902026-07-20
00677964153976Endo Carry-on Procedure Kit401141240114122026-07-20
00677964154089Endo Carry-on Procedure Kit401144940114492026-07-20
00677964154096Endo Carry-on Procedure Kit401146040114602026-07-20
00677964051555Medivators HookupHookup58112CAS2024-04-01
00677964053450Medivators HookupHookup28338CAS2024-04-01
00677964002328Medivators HookupHookup28718CAS2023-04-10
00677964037856Medivators HookupHookup28612CAS2023-04-10
00677964153617Endo Carry-on Procedure Kit401122140112212026-05-26
00677964153624Endo Carry-on Procedure Kit401124240112422026-05-26
00677964153631Endo Carry-on Procedure Kit401123040112302026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995245962Rapicide PA High-Level DisinfectantMEDIVATORS INC.FEB2026-03-06
10724995245969Rapicide PA High-Level DisinfectantMEDIVATORS INC.FEB2026-03-06
00724995244392NASTERIS CORPORATIONFEB2025-10-21
00724995355470NASTERIS CORPORATIONFEB2025-10-21
00724995355487NASTERIS CORPORATIONFEB2025-10-21
40677964055322Medivators HookupMEDIVATORS INC.FEB2025-06-10
40677964054448Medivators HookupMEDIVATORS INC.FEB2025-04-04
40677964054622Medivators HookupMEDIVATORS INC.FEB2025-04-04
00860010835241System 83 RevolveWassenburg Medical, Inc.FEB2025-02-24
04260306710577SugiQuestAlpha GmbH & Co. KGFEB2024-12-02
04260306710584SugiQuestAlpha GmbH & Co. KGFEB2024-12-02
10705037069316EVOTECH™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FEB2024-06-20
00724995225209NASTERIS CORPORATIONFEB2024-06-03
00724995225216NASTERIS CORPORATIONFEB2024-06-03
00724995225223NASTERIS CORPORATIONFEB2024-06-03
00724995225230NASTERIS CORPORATIONFEB2024-06-03
00724995225247NASTERIS CORPORATIONFEB2024-06-03
00724995225254NASTERIS CORPORATIONFEB2024-06-03
00724995225261NASTERIS CORPORATIONFEB2024-06-03
00724995225278NASTERIS CORPORATIONFEB2024-06-03
00724995225285NASTERIS CORPORATIONFEB2024-06-03
00724995225292NASTERIS CORPORATIONFEB2024-06-03
00724995225308NASTERIS CORPORATIONFEB2024-06-03
00724995225315NASTERIS CORPORATIONFEB2024-06-03
00724995225322NASTERIS CORPORATIONFEB2024-06-03
00724995225339NASTERIS CORPORATIONFEB2024-06-03
00724995225346NASTERIS CORPORATIONFEB2024-06-03
00724995225353NASTERIS CORPORATIONFEB2024-06-03
00724995225360NASTERIS CORPORATIONFEB2024-06-03
00724995225377NASTERIS CORPORATIONFEB2024-06-03