FDA.reportPublic FDA data

Guedel Airways (color coded)

Primary DI
30641043816701
Brand
Guedel Airways (color coded)
Company
MERCURY ENTERPRISES, INC.
Model
10-81670
Device description
70MM
Published
2020-10-31
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAEAirway, Oropharyngeal, Anesthesiology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30641043816701PackageGS110In Commercial Distribution
10641043816707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3064104381670130641043816701
1064104381670710641043816707

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
727-573-0088hospitalcustomerservice@mercurymed.com

Regulatory Flags#

DUNS number
032705659
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10641043508473Neo-Tee T-Piece Resuscitator10-508232026-03-26
10641043563311CPR-2 Bag10-563312026-02-12
10641043564608CPR-2 Bag10-564602025-12-16
30641043564602CPR-2 Bag10-564602025-12-16
10641043320006EZflow10-320002016-03-07
10641043320013EZflow10-320012016-03-07
10641043320020EZflow10-320022016-03-09
10641043320037EZflow MAX10-320032016-03-09
10641043320044EZflow MAX10-320042016-03-09
10641043320051EZflow10-320052016-03-09
10641043320068EZflow10-320062016-03-09
10641043320099EZflow MAX10-320092016-03-09
10641043588727Hyperinflation System10-588722025-09-11
10641043566039CPR-2 Bag10-566032025-07-15
30641043566033CPR-2 Bag10-566032025-07-15
10641043913161Neo-Tee T-Piece Resuscitator CircuitM1091316VSM1091316VS2024-02-08
10641043913352Neo-Tee T-Piece Resuscitator CircuitM1091335VSM1091335VS2024-02-08
10641043913659Neo-Tee T-Piece Resuscitator CircuitM1091365VSM1091365VS2024-02-08
10641043553701StatCO2 End Tidal CO2 Detector10-553702016-01-08
30641043913165Neo-Tee T-Piece Resuscitator Circuit10-913162024-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06920687314020INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314037INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314044INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314051INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314068INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314075INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314082INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314099INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314105INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314112INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314129INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314136INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314143INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314150INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314167INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314174INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314181INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314198INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314204INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314211INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314228INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314235INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314242INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314259INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314303INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314310INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314327INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314334INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06946430427632CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2026-08-08
05060112310058LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-08-03