FDA.report

AincA®

Primary DI
B005E1270
Brand
AincA®
Company
ANESTHESIA ASSOCIATES, INC.
Model
E-127
Catalog number
E-127
Device description
Jaw Spreader, Abelson, Package w/ Jaw-Screw and Med. Adult Airway, Styrene/Plastic, Molded in USA
Published
2021-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
B005E1270PrimaryHIBCC0

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(760)744-6561Solutions@AincA.com

Regulatory Flags

DUNS number
002065670
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
true
Sterilization required before use
false

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B005LF619200AincA®LF-619-20LF-619-202023-08-17
B005LF619300AincA®LF-619-30LF-619-302023-08-17
B005LF619400AincA®LF-619-40LF-619-402023-08-17
B005LF619500AincA®LF-619-50LF-619-502023-08-17
B005LF622100AincA®LF-622-10LF-622-102023-08-17
B005LF622200AincA®LF-622-20LF-622-202023-08-17
B005LF622300AincA®LF-622-30LF-622-302023-08-17
B005LF622400AincA®LF-622-40LF-622-402023-08-17
B005LF622500AincA®LF-622-50LF-622-502023-08-17
B005LF715100AincA®LF-715-10LF-715-102023-08-17
B005LF715200AincA®LF-715-20LF-715-202023-08-17
B005LF715300AincA®LF-715-30LF-715-302023-08-17
B005LF715400AincA®LF-715-40LF-715-402023-08-17
B005LF715500AincA®LF-715-50LF-715-502023-08-17

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