FDA.report

MediChoice

Primary DI
30885632101308
Brand
MediChoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
GA5060
Device description
Airway Guedel Plastic Finish Individually Bagged Single Patient Use Black 60 Millimeter Non-Sterile Not Made With Natural Rubber Latex MediChoice
Published
2020-09-01
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
true

Related Records

Product Codes

CodeName
CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Product Code Classifications

CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30885632101308PackageGS110In Commercial Distribution
50885632101302PackageGS110In Commercial Distribution
10885632101304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3088563210130830885632101308
5088563210130250885632101302
1088563210130410885632101304

GMDN Terms

TermDefinition
Oropharyngeal airway, single-useA curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00
Special Storage Condition, Specify00Avoid freezing and excessive heat

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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