FDA.reportPublic FDA data

XVIVO Click Adapter

Primary DI
07350069520302
Brand
XVIVO Click Adapter
Company
Xvivo Perfusion AB
Model
19125
Catalog number
19125
Device description
Intended as an adapter between the Perfadex® Plus bag and a tubing set with a standard spike.
Published
2018-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NEPSystem/Device, Pharmacy Compounding

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEPSystem/Device, Pharmacy CompoundingGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350069520302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350069520302073500695203027350069520302

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
559895730
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350069520623XVIVO Disposable Lung Kit 19046190462025-11-10
07350069520401XVIVO Disposable Lung Kit19046190462023-09-29
07350069520234PERFADEX Plus®19800198002019-12-04
07350069520241PERFADEX Plus®19900199002019-12-04
07350069520296PERFADEX® Plus19950199502018-09-19
07350069520289PERFADEX Plus (Click US)19850198502019-12-04
07350069520036STEEN Solution™19004190042015-10-15
07350069520050Perfadex with THAM19017190172016-06-13
07350069520067Perfadex with THAM19018190182016-06-13
07350069520142XVIVO Lung Disposables Kit19035190352015-10-15
07350069520500XVIVO Lung Cannula Set II™ 19023190232021-10-01
07350069520074XVIVO Organ Chamber™19020190202015-10-15
07350069520098XVIVO Lung Cannula Set™19022190222015-10-15
07350069520111XVIVO PGM Disposable Sensors™ 19033190332015-10-15
07350069520425XVIVO Click Adapter19024190242021-10-29
07350069520104XVIVO Perfusion System (XPS™)19030190302015-10-15
07350069520043Silicon Tubing Set19005190052016-11-11

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Primary DI, Brand, Company table
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