FDA.report

Vacutore® CO2 Source Tubing Adapter

Primary DI
14897106950215
Brand
Vacutore® CO2 Source Tubing Adapter
Company
GA Health Company Limited
Model
GAR093
Published
2020-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NKCTubing/Tubing With Filter, Insufflation, Laparoscopic

Product Code Classifications

CodeDeviceSpecialtyClass
NKCTubing/Tubing With Filter, Insufflation, LaparoscopicObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14897106950215PackageGS1100In Commercial Distribution
24897106950212PackageGS1100In Commercial Distribution
04897106950218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1489710695021514897106950215
2489710695021224897106950212
04897106950218048971069502184897106950218

GMDN Terms

TermDefinition
Endoscope assembly adaptorA connecting component of a flexible or rigid endoscope assembly intended to be used to join one or more endoscope elements to create a complete endoscope assembly, or to enable the connection of other devices (e.g., a laser). It may also be fitted with stop-cocks or instrument ports for the introduction of devices (e.g., catheters), fluids, gases, or to perform aspiration. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
686908512
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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