AccessGUDID - DEVICE: MedStream (00842472107098)

GUDID

Device Identifier (DI) Information

Brand Name: MedStream
Version or Model: MSDC-C23361
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MSDC-C23361
Company Name: MEDICAL SPECIALTIES DISTRIBUTORS, LLC

Primary DI Number: 00842472107098
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 153608369 *Terms of Use

Device Description: DRESSING CHANGE KIT - CENTRAL LINE TRAY

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
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?
61345	Vascular catheterization support/maintenance kit, non-medicated	A collection of non-dedicated devices intended for catheterization support and/or catheter maintenance (e.g., dressing change, catheter flushing) associated with peripheral venous, central venous, and/or arterial catheterization. Primarily intended to be used at the patient’s bedside, the kit includes devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution. Neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OXQ	Dressing Change 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: 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: 075aa480-0e87-4530-9505-2cdfb0c70132
Public Version Date: June 19, 2024
Public Version Number: 4
DI Record Publish Date: June 28, 2019