FDA.report

MediChoice

Primary DI
30885632112939
Brand
MediChoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
INSF1003
Device description
Tubing Insufflation 0.1 Micron Filter Luer Funnel Connect Stryker DEHP-Free Polyvinyl Chloride 10 Feet Sterile Not Made With Natural Rubber Latex MediChoice
Published
2020-09-23
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

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
30885632112939PackageGS110In Commercial Distribution
50885632112933PackageGS16In Commercial Distribution
10885632112935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3088563211293930885632112939
5088563211293350885632112933
1088563211293510885632112935

GMDN Terms

TermDefinition
Endoscopic insufflation tubing set, single-useA collection of sterile flexible tubing intended to be used as a conduit to deliver a medical gas [e.g., carbon dioxide (CO2), medical air] from its source for insufflation during an endoscopic (including laparoscopic, arthroscopic) procedure. It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
007941230
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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