Pre-Processing Sink

GUDID PPS83S6

A device intended to flush endoscopes.

Wassenburg Medical, Inc.

Endoscope washer/disinfector
Primary Device IDPPS83S6
NIH Device Record Keyd2414237-917a-4e6b-b66c-efa704f62eba
Commercial Distribution Discontinuation2018-08-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePre-Processing Sink
Version Model Number83-S6
Company DUNS118762097
Company NameWassenburg Medical, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone2153641477
Emailinfo@customultrasonics.com
Phone2153641477
Emailinfo@customultrasonics.com
Phone2153641477
Emailinfo@customultrasonics.com
Phone2153641477
Emailinfo@customultrasonics.com
Phone2153641477
Emailinfo@customultrasonics.com
Phone2153641477
Emailinfo@customultrasonics.com
Phone2153641477
Emailinfo@customultrasonics.com
Phone2153641477
Emailinfo@customultrasonics.com
Phone2153641477
Emailinfo@customultrasonics.com
Phone2153641477
Emailinfo@customultrasonics.com
Phone2153641477
Emailinfo@customultrasonics.com
Phone2153641477
Emailinfo@customultrasonics.com
Phone2153641477
Emailinfo@customultrasonics.com
Phone2153641477
Emailinfo@customultrasonics.com
Phone2153641477
Emailinfo@customultrasonics.com
Phone2153641477
Emailinfo@customultrasonics.com
Phone2153641477
Emailinfo@customultrasonics.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Forklift
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Forklift
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Forklift
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Forklift
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Forklift
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Forklift
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Forklift
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Forklift
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Forklift
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Forklift
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Forklift
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Forklift
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Forklift
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Forklift
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Forklift
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Forklift
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Forklift
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCPPS83S6 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FEBAccessories, Cleaning, For Endoscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2023-07-03
Device Publish Date2017-10-31

On-Brand Devices [Pre-Processing Sink]

PPS83S8A device intended to flush endoscopes.
PPS83S6A device intended to flush endoscopes.

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