FDA.reportPublic FDA data

Silicon Tubing Set

Primary DI
07350069520043
Brand
Silicon Tubing Set
Company
Xvivo Perfusion AB
Model
19005
Catalog number
19005
Device description
The Silicone Tubing Set™ is intended for flushing of donor lungs in preparation for transplantation.
Published
2016-11-11
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

Contact Domains#

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
07350069520043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350069520043073500695200437350069520043

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 303 395 9171info@xvivoperfusion.com

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
07350069520302XVIVO Click Adapter19125191252018-09-19

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Primary DI, Brand, Company table
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