FDA.reportPublic FDA data

Universal Stylette Bougie Assisted Cricothyrotomy (USBCR)

Primary DI
00850062467132
Brand
Universal Stylette Bougie Assisted Cricothyrotomy (USBCR)
Company
Altitude Technologies Inc.
Model
021555
Device description
The Universal Stylette Bougie Assisted Cricothyrotomy (USBCR) contains the necessary items to establish a surgical airway with a universal stylet bougie guide, when other methods are unsuccessful, as requested by the US Military.
Published
2025-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OGPCricothyrotomy Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGPCricothyrotomy KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850062467132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850062467132008500624671328500624671320850062467132

GMDN Terms#

Term, Definition table
TermDefinition
Cricothyrotomy kit, single-useA collection of sterile devices designed to perform a cricothyrotomy (an incision through the skin and cricothyroid) providing airway access within seconds allowing for immediate ventilation of the patient and necessary suction procedures. It is used to open a patient's airway in emergency interventions, e.g., accidental blockage to the upper airway tract, and prior to tracheostomy. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-766-1365sales@chinookmed.com

Regulatory Flags#

DUNS number
621904622
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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