FDA.reportPublic FDA data

Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX

Primary DI
03701354407701
Brand
Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX
Company
PLASMABIOTICS
Model
PW90 2C-G-D
Device description
Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX 90 and i10 series with double operating channel
Published
2021-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701354407701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701354407701037013544077013701354407701

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope clean-storage systemA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height3Centimeter
Length34Centimeter
Width23Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure0.9 Inches of Mercury1.1 Inches of Mercury
Storage Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
262972663
Device count
1
Premarket exempt
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701354404403Media roll with 1100 labels for TSC printerEterm2021-05-14
03701354404502Thermal transfer ribbon 74 m for TSC printerFterm2021-05-14
03701354404601Self-adhesive bar-code, 10 unitsCBar-AC2021-05-14
03701354404700Coplex bar-code (to attach), 10 unitsCBar-CP2021-05-14
03701354404809Stainless steel bar-code (to attach), 10 unitsCBar-IN2021-05-14
03701354404908Demo Flight caseFCD-Typhoon2021-05-14
03701354405004Endoscope surrogate (channel system) and its connection set for demonstration puSG-endo2021-05-14
03701354405103Silicone connection set for ultrasound bronchoscopes PENTAX EB19-J10UPP EEB-J102021-05-14
03701354405110Autoclavable version of PP EEB-J10PP EEB-J10/A2021-05-14
03701354405202Silicone connection set for colonoscopes, gastroscopes and duodenoscopes FUJIFILFg5W 2C-G-D2021-05-14
03701354405219Autoclavable version of Fg5W 2C-G-DFg5W 2C-G-D/A2021-05-14
03701354405400Silicone connection set for cystoscopes (and ureteroscopes) OLYMPUS CYF-4A/5A/VAOly C2021-05-14
03701354405417Autoclavable version of Oly COly C/A2021-05-14
03701354406704Polyurethane tube, int. diam. 4 mm, ext. diam. 6 mm, length 30 mTPU6-PT2021-05-14
03701354406803Polyurethane tube, int. diam. 5 mm, ext. diam. 8 mm, length 30 mTPU8-PT2021-05-14
03701354406902Metallic push-in connectors for MD-airmed CHRR-CH2021-05-14
03701354407008Push-in connectors for PU tubesRR-DY682021-05-14
03701354407107Gas flowrate meterGFRM-BH2021-05-14
03701354407206Analogue manometerAMano2021-05-14
03701354407305Ozone test strips (12 strips per box)OZTS-MN2021-05-14

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