FDA.reportPublic FDA data

Disposable guedel airway, 40mm

Primary DI
04716770611402
Brand
Disposable guedel airway, 40mm
Company
BESMED HEALTH BUSINESS CORP.
Model
AW-61140
Device description
Disposable guedel airway, 40mm
Published
2017-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
04716770611402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04716770611402047167706114024716770611402

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

Regulatory Flags#

DUNS number
658023775
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
04716770701127HME W/Luer lock port (Dead space 45ml)FL-701122026-02-11
04716770701158Angled HME with luer lock portFL-701152026-02-11
04716770702230Bacterial Filter (Dead space 32ml)FL-702232026-02-11
14716770703029HMEF W/Luer lock port (Dead space 45ml)FL-703022026-02-11
14716770703036HMEF W/Luer lock port (Dead space 60ml)FL-703032026-02-11
14716770703067HMEF (Dead space 60ml)FL-703062026-02-11
04716770834221ICU gas sampling packOT-834222022-08-08
04716770834238ICU gas sampling pack with flowmeterOT-834232022-08-08
04716770144306Straight Connector 15F/22M, 15M W/PORT & CAPCT-143302021-01-07
04716770857398FLOW SENSOR, ADULTPO-857392021-01-07
04716770790015Elbow connetor 18MM ID for nebulizerMP-790012017-12-13
04716770791043MOUTH PIECE (OD:18mm,22mm)MP-791042017-12-13
04716770791081MOUTH PIECE(OD:22mm)MP-791082017-12-13
04716770791098MOUTH PIECE (ID:18mm, OD:19.5mm)MP-791092017-12-13
04716770791203Nebulizer,pacifierMP-791202017-12-13
04716770000176SILICONE ADULT 1000ML RESUSCITATOR W/ POP-OFF 60CM H2O, L TYPE ADAPTERRE-231722016-05-23
04716770000183 SINGLE USE ADULT 1000ML RESUSCITATOR W/O POP-OFFRE-234122016-05-23
04716770000190 SINGLE USE CHILD 500ML RESUSCITATOR W/ POP-OFF 40CM H2O (ALL IN ONE-INTAKE VALVRE-245102016-05-23
04716770244372SINGLE USE ADULT RESUSCITATOR BALL 1600ML W/POP-OFF , 60cm H2O & MANOMETER PORTRE-244372016-05-23
04716770005607Digital tens one channelBE-5602016-09-07

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