FDA.report

SunMed

Primary DI
20889483000400
Brand
SunMed
Company
SUNMED, LLC
Model
1-1501-50
Catalog number
1-1501-50
Device description
Infant Traditional Guedel Airway
Published
2023-03-21
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

Contact Domains

Product Codes

CodeName
CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Product Code Classifications

CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20889483000400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088948300040020889483000400

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.

Device Sizes

TypeValueUnit
Length5Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)433-2797info@sun-med.com

Regulatory Flags

DUNS number
069009268
Device count
1
DM exempt
true
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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