FDA.report

FLUID CONTROL

Primary DI
04055207054628
Brand
FLUID CONTROL
Company
Richard Wolf GmbH
Model
2203011
Catalog number
2203.011
Device description
ARTHRO IRRIGATION PUMP 150MMHG for arthroscopy , for fluid management of irrigation fluid in joints, with instrument recognition, LCD Display, connec
Published
2017-07-21
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
HRXARTHROSCOPE

Product Code Classifications

CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207054628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207054628040552070546284055207054628

GMDN Terms

TermDefinition
Basic roller pumpA mains electricity (AC-powered) pump using rotating rollers which squeeze a soft-walled tubing against the housing wall, thus producing a pulsatile pumping effect. It is typically used for the delivery of precise quantities of liquids (e.g., for laboratory devices and equipment). For the roller pump used in open heart surgery see the appropriate GMDN code.

Device Sizes

TypeValueUnit
Pressure19.9983KiloPascal

Sterilization Methods

Method

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

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

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