FDA.reportPublic FDA data

Endoscope clean-storage system

Definition
A mobile, mains electricity (AC-powered) assembly of devices intended to prepare, bag, label and register disinfected and sterilized endoscopes prior to long-term storage. It typically includes: 1) a fluid preparation assembly such as fluid pump, tubing and a preparation solution (e.g., hydrogen peroxide solution); 2) devices intended to achieve sealed-storage such as trays, sterile liners, vacuum bags, and a vacuum pump; 3) labelling/registration devices (i.e., bar-code printer and bar-code reader); and 4) a computer with integrated software for process/data management. It is not intended to clean, disinfect or sterilize but to maintain the sterilized/disinfected state of the endoscope.
GUDID devices
81
Last updated
2021-05-24 17:45:07

Related Product Codes

CodeDeviceSpecialtyClassDevices
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry181

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
03701354404403Media roll with 1100 labels for TSC printerPLASMABIOTICSEterm2021-05-14
03701354404502Thermal transfer ribbon 74 m for TSC printerPLASMABIOTICSFterm2021-05-14
03701354404601Self-adhesive bar-code, 10 unitsPLASMABIOTICSCBar-AC2021-05-14
03701354404700Coplex bar-code (to attach), 10 unitsPLASMABIOTICSCBar-CP2021-05-14
03701354404809Stainless steel bar-code (to attach), 10 unitsPLASMABIOTICSCBar-IN2021-05-14
03701354404908Demo Flight casePLASMABIOTICSFCD-Typhoon2021-05-14
03701354405004Endoscope surrogate (channel system) and its connection set for demonstration puPLASMABIOTICSSG-endo2021-05-14
03701354405103Silicone connection set for ultrasound bronchoscopes PENTAX EB19-J10UPLASMABIOTICSPP EEB-J102021-05-14
03701354405110Autoclavable version of PP EEB-J10PLASMABIOTICSPP EEB-J10/A2021-05-14
03701354405202Silicone connection set for colonoscopes, gastroscopes and duodenoscopes FUJIFILPLASMABIOTICSFg5W 2C-G-D2021-05-14
03701354405219Autoclavable version of Fg5W 2C-G-DPLASMABIOTICSFg5W 2C-G-D/A2021-05-14
03701354405400Silicone connection set for cystoscopes (and ureteroscopes) OLYMPUS CYF-4A/5A/VAPLASMABIOTICSOly C2021-05-14
03701354405417Autoclavable version of Oly CPLASMABIOTICSOly C/A2021-05-14
03701354406704Polyurethane tube, int. diam. 4 mm, ext. diam. 6 mm, length 30 mPLASMABIOTICSTPU6-PT2021-05-14
03701354406803Polyurethane tube, int. diam. 5 mm, ext. diam. 8 mm, length 30 mPLASMABIOTICSTPU8-PT2021-05-14
03701354406902Metallic push-in connectors for MD-airmed CHPLASMABIOTICSRR-CH2021-05-14
03701354407008Push-in connectors for PU tubesPLASMABIOTICSRR-DY682021-05-14
03701354407107Gas flowrate meterPLASMABIOTICSGFRM-BH2021-05-14
03701354407206Analogue manometerPLASMABIOTICSAMano2021-05-14
03701354407305Ozone test strips (12 strips per box)PLASMABIOTICSOZTS-MN2021-05-14
03701354407701Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX PLASMABIOTICSPW90 2C-G-D2021-05-14
03701354407718Autoclavable version of PW90 2C-G-DPLASMABIOTICSPW90 2C-G-D/A2021-05-14
037013544078001000 red labels “To disinfect”PLASMABIOTICSEBag-RED2021-05-14
03701354407909NIST medical air probe 4 bar PLASMABIOTICSNIST-CH2021-05-14
03701354407916NIST medical air probe 7 bar PLASMABIOTICSNIST-CH-MA42021-05-14
03701354400214Printer for traceability labelsPLASMABIOTICSImp-TSC2021-05-13
03701354400313Barcode scannerPLASMABIOTICSLecCB-HW2021-05-13
03701354400504Gas pressure regulator for medical airPLASMABIOTICSMD-airmed CH2021-05-13
03701354400603Compressed air gun set with Y-connector, gas supply tubes and pressure regulatorPLASMABIOTICSHD-sfl2021-05-13
03701354400702Silicone connection set for colonoscopes, gastroscopes and duodenoscopes FUJIFILPLASMABIOTICSFg5W C-G-D2021-05-13
03701354400719Autoclavable version of Fg5W C-G-DPLASMABIOTICSFg5W C-G-D/A2021-05-13
03701354400801Silicone connection set for colonoscopes, gastroscopes and duodenoscopes FUJIFILPLASMABIOTICSF700 C-G-D2021-05-13
03701354400818Autoclavable version of F700 C-G-DPLASMABIOTICSF700 C-G-D/A2021-05-13
03701354400900Standard connection set for bronchoscopes FUJIFILM series EB-530, EB-580, FB-120PLASMABIOTICSFg5 B-Bp2021-05-13
03701354400917Autoclavable version of Fg5 B-BpPLASMABIOTICSFg5 B-Bp/A2021-05-13
03701354401006Standard connection set for ultrasound bronchoscopes FUJIFILM EB-530USPLASMABIOTICSFg5 EB2021-05-13
03701354401013Autoclavable version of Fg5 EBPLASMABIOTICSFg5 EB/A2021-05-13
03701354401105Silicone connection set for ultrasound endoscopes FUJIFILM EG-530UR/UTPLASMABIOTICSFg5 E5302021-05-13
03701354401112Autoclavable version of Fg5 E530PLASMABIOTICSFg5 E530/A2021-05-13
03701354401204Silicone connection set for ultrasound endoscopes F+G18UJIFILM EG-580UR/UTPLASMABIOTICSFg5 E5802021-05-13
03701354401211Autoclavable version of Fg5 E580PLASMABIOTICSFg5 E580/A2021-05-13
03701354401303Silicone connection set for colonoscopes, gastroscopes and duodenoscopes OLYMPUSPLASMABIOTICSOW C-G-D2021-05-13
03701354401310Autoclavable version of OW C-G-DPLASMABIOTICSOW C-G-D/A2021-05-13
03701354401402Silicone connection set for colonoscopes, gastroscopes and duodenoscopes OLYMPUSPLASMABIOTICSOW 2C-G-D2021-05-13
03701354401419Autoclavable version of OW 2C-G-DPLASMABIOTICSOW 2C-G-D/A2021-05-13
03701354401501Silicone connection set for ultrasound endoscopes OLYMPUS UE/UM seriesPLASMABIOTICSOW E2021-05-13
03701354401518Autoclavable version of OW EPLASMABIOTICSOW E/A2021-05-13
03701354401600Silicone connection set for ultrasound endoscopes OLYMPUS UC/UCT seriesPLASMABIOTICSOW E UCT2021-05-13
03701354401617Autoclavable version of OW E UCTPLASMABIOTICSOW E UCT/A2021-05-13
03701354401709Silicone connection set for fiber- and video-bronchoscopes OLYMPUSPLASMABIOTICSOO P2021-05-13
03701354401716Autoclavable version of OO PPLASMABIOTICSOO P/A2021-05-13
03701354401808Silicone connection set for ultrasound bronchoscopes OLYMPUSPLASMABIOTICSOO P EB2021-05-13
03701354401815Autoclavable version of OO P EBPLASMABIOTICSOO P EB/A2021-05-13
03701354401907Silicone connection set for standard and pediatric bronchoscopes PENTAX, STORZ aPLASMABIOTICSOP B-Bp2021-05-13
03701354401914Autoclavable version of OP B-BpPLASMABIOTICSOP B-Bp/A2021-05-13
03701354402003Silicone connection set for tracheal intubation scopes OLYMPUS LF-GP/DP/TPPLASMABIOTICSOO LF2021-05-13
03701354402010Autoclavable version of OO LFPLASMABIOTICSOO LF/A2021-05-13
03701354402218Autoclavable version of PW C-G-D 90PLASMABIOTICSPW C-G-D 90/A2021-05-13
03701354402508Silicone connection set for ultrasound endoscopes PENTAX 70K and J10 seriesPLASMABIOTICSPW Enew2021-05-13
03701354402515Autoclavable version of PW EnewPLASMABIOTICSPW Enew/A2021-05-13
03701354402607Silicone connection set for ultrasound bronchoscopes PENTAX EB-1970UKPLASMABIOTICSPP EEB2021-05-13
03701354402614Autoclavable version of PP EEBPLASMABIOTICSPP EEB/A2021-05-13
03701354402706Silicone connection set for video- bronchoscopes PENTAX J10 seriesPLASMABIOTICSPP EB-J102021-05-13
03701354402713Autoclavable version of PP EB-J10PLASMABIOTICSPP EB-J10/A2021-05-13
03701354402805Silicone connection set for colonoscopes, gastroscopes and duodenoscopes STORZPLASMABIOTICSSW C-G-D2021-05-13
03701354402812Autoclavable version of SW C-G-DPLASMABIOTICSSW C-G-D/A2021-05-13
03701354402904Silicone connection set for cystoscopes and ureteroscopes WOLF, STORZ, OLYMPUS wPLASMABIOTICSWol C2021-05-13
03701354402911Autoclavable version of Wol CPLASMABIOTICSWol C/A2021-05-13
03701354403000Silicone connection set for cystoscopes and ureteroscopes WOLF, STORZ, OLYMPUS, PLASMABIOTICSWol U2021-05-13
03701354403017Autoclavable version of Wol UPLASMABIOTICSWol U/A2021-05-13
03701354403109Silicone connection set for double-channel ureteroscope WOLF CobraPLASMABIOTICSWol U2c2021-05-13
03701354403116Autoclavable version of Wol U2cPLASMABIOTICSWol U2c/A2021-05-13
03701354404007Storage connection set (for plasma injection)PLASMABIOTICSPBag-inj2021-05-13
03701354404014Autoclavable version of PBag-injPLASMABIOTICSPBag-inj/A2021-05-13
037013544041061000 pre-printed labels for manual traceabilityPLASMABIOTICSEBag2021-05-13
037013544042051000 double-layer labels, green and red PLASMABIOTICSEBag-DC2021-05-13
03701354404304Shutters 1000 unitsPLASMABIOTICSOBag2021-05-13
03701354400115PlasmaTYPHOONPLASMABIOTICSTyphoon-V2TD1202021-05-12
03701354403802Standard PlasmaBAG, size: 60cm x 50cm, 400 units packagingPLASMABIOTICSPBag2021-05-12
03701354403901XXL PlasmaBAG, size: 84cm x 60cm, 300 units packagingPLASMABIOTICSPBagXXL2021-05-12