FDA.reportPublic FDA data

Vacuum Pump Tubing

Primary DI
17350025915644
Brand
Vacuum Pump Tubing
Company
Vitrolife Sweden AB
Model
17201
Published
2019-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAZTubing, Noninvasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAZTubing, NoninvasiveGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17350025915644PackageGS110In Commercial Distribution
07350025915647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1735002591564417350025915644
07350025915647073500259156477350025915647

GMDN Terms#

Term, Definition table
TermDefinition
Vacuum tubing, single-useA sterile, flexible, cylindrical device used as a connection line between a vacuum source and a medical device, medical equipment, or a medical system that is dependent upon suction to operate or function. It is typically made of a malleable plastic or silicone material and is designed with a thick wall to prevent collapse due to the negative pressure of the vacuum; it is available in a variety of lengths, including standard coil lengths. This device is used when sterile conditions are required, e.g., for an autologous blood transfusion system. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
631805488
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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Primary DI, Brand, Model table
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07350025911625Ultrasound Transducer Cover142202025-04-16
07350025911632Ultrasound Transducer Cover142192025-04-16
17350025911615Ultrasound Transducer Cover142212025-04-16
17350025911622Ultrasound Transducer Cover142202025-04-16
17350025911639Ultrasound Transducer Cover142192025-04-16
07350025914220RapidWarm Blast101202016-09-13
17350025910762HYASE-10X101762021-12-31
07350025910604Gx-IVF101712021-05-21
07350025910611Gx-TL101722021-05-21
07350025910628Gx-MOPS PLUS101732021-05-21
07350025910314OVOIL HEAVY101742020-08-25
07350025914800RapidVit Oocyte101212019-12-14
07350025914817RapidWarm Oocyte101222019-12-14
17350025910274ICSI101112016-09-13
17350025914784SpermGrad101382016-09-13
17350025914791SpermGrad101392016-09-13

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