FDA.report

AincA®

Primary DI
B005004780
Brand
AincA®
Company
ANESTHESIA ASSOCIATES, INC.
Model
00-478
Catalog number
00-478
Device description
Stylet, Suction/Intubation, Malleable, 15" Long w/5/16" tip, Copper (Use w/ 00-479 Stop, Optional)
Published
2021-03-31
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
false

Related Records

Contact Domains

Product Codes

CodeName
BSRSTYLET, TRACHEAL TUBE

Product Code Classifications

CodeDeviceSpecialtyClass
BSRStylet, Tracheal TubeAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B005004780PrimaryHIBCC0

GMDN Terms

TermDefinition
Artificial airway stylet, reusableA long stiffening wire/rod designed for insertion within the lumen of an artificial airway tube (e.g., endotracheal tube, bronchial tube) to stiffen and/or maintain the shape of the tube to facilitate introduction (intubation). It is designed to be slightly shorter than the tube to avoid damage to the airway during passage, and is withdrawn after intubation has been completed. This is a reusable device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
002065670
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
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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B005LF622500AincA®LF-622-50LF-622-502023-08-17
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B005LF715200AincA®LF-715-20LF-715-202023-08-17
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B005LF715400AincA®LF-715-40LF-715-402023-08-17
B005LF715500AincA®LF-715-50LF-715-502023-08-17

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