FDA.reportPublic FDA data

NA

Primary DI
00724995214630
Brand
NA
Company
STERIS CORPORATION
Model
Quick Connect
Catalog number
QFC1777E
Device description
The Quick Connect for Fujifilm GI Endoscopes is used with the C1160E Universal Flexible Endoscope Processing Tray in the SYSTEM 1E and, or SYSTEM 1 endo Liquid Chemical Processing Systems.
Published
2021-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MEDSterilant, medical devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEDSterilant, Medical DevicesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090036000
K101409000
K102462000
K113520000
K131078000
K161683000
K170956000
K173256000
K180342000
K182827000
K190104000
K191343000
K192929000
K210737000
K211607000
K222615000
K232914000
K251666000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090036000SYSTEM 1.5 STERILE PROCESSING SYSTEMSTERIS Corporation2010-04-05MED
K101409000SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEMSTERIS Corporation2010-08-02MED
K102462000SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEMSTERIS Corporation2010-09-21MED
K113520000SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEMSTERIS Corporation2012-02-21MED
K131078000SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEMSTERIS Corporation2013-07-05MED
K161683000SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation2016-08-05MED
K170956000SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation2017-09-22MED
K173256000System 1 endo Liquid Chemical Sterilant Processing SystemSTERIS Corporation2018-03-02MED
K180342000SYSTEM 1E Liquid Chemical Sterilant Processing SystemSteris Corporations2018-04-04MED
K182827000SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900STERIS Corporation2019-01-31MED
K190104000SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing SystemSteris Corporations2019-03-22MED
K191343000SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900STERIS Corporation2019-09-05MED
K192929000SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900STERIS Corporation2019-12-10MED
K210737000SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant ConcentrateSTERIS Corporation2021-05-12MED
K211607000SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant ConcentrateSTERIS Corporation2021-09-07MED
K222615000SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant ConcentrateSTERIS Corporation2022-09-28MED
K232914000SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)STERIS Corporation2023-10-03MED
K251666000SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900STERIS Corporation2026-04-08MED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995214630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995214630007249952146307249952146300724995214630

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
868205779
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995248444Snowden-Pencer886118V886118V2026-10-27
00724995248451Snowden-Pencer886122V886122V2026-10-27
00724995248468Snowden-Pencer886127V886127V2026-10-27
10885403035562V. MuellerCH8680CH86802020-04-15
10885403035579V. MuellerCH8680-001CH86800012020-04-15
10885403035586V. MuellerCH8681CH86812020-04-15
10885403022470V. MuellerRH600RH6002018-09-14
10885403092084V. MuellerOP0907-601OP09076012018-09-05
10885403092091V. MuellerOP0907-602OP09076022018-09-05
10885403099120V. MuellerOP5000OP50002018-09-07
10885403099137V. MuellerOP5005OP50052018-09-07
10885403099144V. MuellerOP5500OP55002018-09-07
10885403099182V. MuellerOP5505OP55052018-09-07
10885403099199V. MuellerOP5510OP55102018-09-07
10885403099205V. MuellerOP5520OP55202018-09-07
10885403099625V. MuellerOP5666OP56662019-01-02
10885403099717V. MuellerOP5700OP57002019-01-02
10885403099779V. MuellerOP5760OP57602019-01-02
10885403099786V. MuellerOP5761OP57612019-01-02
10885403104909V. MuellerOS4610OS46102018-09-10

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