AccessGUDID - DEVICE: Motion Medical Distributing (15060498451908)

GUDID

Device Identifier (DI) Information

Brand Name: Motion Medical Distributing
Version or Model: 1634
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1634
Company Name: Haslam Medical, Inc.

Primary DI Number: 15060498451908
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 604208868 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45926	Cricothyrotomy kit, single-use	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OGP	Cricothyrotomy Kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bc464a6a-b2fa-466c-9c75-8727d8808387
Public Version Date: September 26, 2019
Public Version Number: 1
DI Record Publish Date: September 18, 2019