FDA.report

Motion Medical Distributing

Primary DI
15060498451908
Brand
Motion Medical Distributing
Company
Haslam Medical, Inc.
Model
1634
Catalog number
1634
Device description
Cricothyrotomy Kit #1634 Contents: (1) ET Tube 6.0mm, (1) Inflation Syringe 10mL, (1) Scalpel #10, (1) Alcohol Prep Pad LG, (1) Sponge 4x4 2/Pk, (1) Tracheal Retractor, (1) Pocket Bougie-To-Go, (1) Twill Tape 0.25x36yds
Published
2019-09-18
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
15060498451908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1506049845190815060498451908

GMDN Terms

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

Regulatory Flags

DUNS number
604208868
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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

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Other Devices Sharing Product Codes

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