AccessGUDID - DEVICE: Professional Medical Surgical Supply, Inc. d / b / a International Direct (00814125010994)

GUDID

Device Identifier (DI) Information

Brand Name: Professional Medical Surgical Supply, Inc. d / b / a International Direct
Version or Model: 600-TKIT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 600-TKIT
Company Name: PROFESSIONAL MEDICAL-SURGICAL SUPPLY, INCORPORATED

Primary DI Number: 00814125010994
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042850073 *Terms of Use

Device Description: Compliance Trach Care Kit, ST

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
14099	Tracheostomy kit, single-use	A collection of sterile surgical instruments, dressings/swabs, syringe, dilators, tracheostomy tubes and other items intended to be used to create a percutaneous opening in the trachea (tracheotomy) for the insertion of a tracheostomy tube to relieve upper airway obstruction and to facilitate ventilation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OGV	Tracheostomy cleaning tray

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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Weight: 55 Gram

Device Record Status

Public Device Record Key: 919e0602-6088-453a-ad6f-70f4bd623f3a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016