FDA.report

Versicon®

Primary DI
04250337104018
Brand
Versicon®
Company
Joimax GmbH
Model
JPPL0350
Device description
Disposable Patient Line for joimax® Pump System
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FQHLavage, Jet

Product Code Classifications

CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04250337104025PackageGS120In Commercial Distribution
04250337114093PackageGS12In Commercial Distribution
04250337104018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04250337104025042503371040254250337104025
04250337114093042503371140934250337114093
04250337104018042503371040184250337104018

GMDN Terms

TermDefinition
Surgical irrigation tubing set, single-useA collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+49721255140quality@joimax.com

Regulatory Flags

DUNS number
344267187
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04250337118619Vaporace® Probe bipolar, Area 270 mm – 3.5 mmJVAPA270352025-02-14
04250337118640Vaporace® Probe bipolar, Area 320 mm – 3.5 mmJVAPA320352025-02-14
04250337118978Vaporace® Hand Piece, bipolarJVAH100102025-02-14
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04250337101741iLESSYS®TSR25010TSR250102022-12-30
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