FDA.report

TMM-CR (Tactical Medical Module - Cricothyroidotomy)

Primary DI
00863970000438
Brand
TMM-CR (Tactical Medical Module - Cricothyroidotomy)
Company
Chinook Medical Gear
Model
01364
Published
2018-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
OGPCricothyrotomy Kit

Product Code Classifications

CodeDeviceSpecialtyClass
OGPCricothyrotomy KitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00863970000438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00863970000438008639700004388639700004380863970000438

GMDN Terms

TermDefinition
Airway needleA sterile, sharp bevel-edged, hollow tubular metal instrument typically used to pierce the throat through to the trachea to establish airway patency. It is especially used to perform cricothyroidotomy in emergency cases of respiratory obstruction. It is typically used by emergency medical services (EMS). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
621904622
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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