FDA.report

ADC®

Primary DI
00634782002299
Brand
ADC®
Company
AMERICAN DIAGNOSTIC CORP
Model
4080-100
Catalog number
4080-100
Device description
Berman Airway, Medium, 80mm,Size 3, 100/cs, Green
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CAEAirway, Oropharyngeal, Anesthesiology

Product Code Classifications

CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00634782002299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782002299006347820022996347820022990634782002299

GMDN Terms

TermDefinition
Oropharyngeal airway, reusableA 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 reusable device.

Device Sizes

TypeValueUnit
Length80Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-232-2670info@adctoday.com

Regulatory Flags

DUNS number
108999095
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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