AccessGUDID - DEVICE: Stradis Medical, LLC. (M752ACC25501)

GUDID

Device Identifier (DI) Information

Brand Name: Stradis Medical, LLC.
Version or Model: ACC-2550
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: STRADIS MEDICAL, LLC

Primary DI Number: M752ACC25501
Issuing Agency: HIBCC
Commercial Distribution End Date: January 10, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 174262477 *Terms of Use

Device Description: PICC Kit

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):	Yes
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?
61345	Arterial/central venous catheterization support/maintenance kit, non-medicated	A collection of devices intended to support the catheterization procedure of an artery and/or central vein (large veins of the upper body), and/or to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). 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
OWL	Peripheral Catheter Insertion Kit

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: aa125cc8-d6d4-48dd-a959-04dd25783337
Public Version Date: January 11, 2023
Public Version Number: 5
DI Record Publish Date: January 29, 2018