FDA.report

NA

Primary DI
04055207008591
Brand
NA
Company
Richard Wolf GmbH
Model
163904
Catalog number
163.904
Device description
PRESSURE EQUALIZATION VALVE reusable
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FAJCystoscope and accessories, flexible/rigid

Product Code Classifications

CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207008591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207008591040552070085914055207008591

GMDN Terms

TermDefinition
Endoscope leak tester, mechanicalA hand-operated device used to test a flexible endoscope for leaks from its internal channels. It is connected to the endoscope using tubing with connectors to subject the channels to a build-up of air pressure that is created with a hand pump (a bulb). Its manometer will display the pressure and leakage is indicated by a fall in pressure observed on the manometer gauge. It is typically used by healthcare personnel who use endoscopes to validate the patency of the endoscope prior to clinical use, or to substantiate suspicion of a leakage. This process is used as a first line test for early detection of pinhole leaks to minimize inadvertent incidences with the patient.

Sterilization Methods

Method
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
Hydrogen Peroxide

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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