AccessGUDID - DEVICE: Side Ported Needle

GUDID

Device Identifier (DI) Information

Brand Name: Side Ported Needle - 20G
Version or Model: 0295-007-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: C2DX, INC.

Primary DI Number: 10850007350182
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 116981210 *Terms of Use

Device Description: Side Ported Needle - 20G

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:	No
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?
58296	Compartmental-pressure monitoring system, single-use	An assembly of devices designed to measure and display, periodically or continuously, the interstitial pressure in a closed fascial compartment of muscle. It typically consists of a battery-powered, hand-held, pressure-measuring instrument with a display and connected devices used to access the muscle compartment (e.g., a prefilled syringe, one-way valves, and a side ported noncoring needle and/or slit catheter). It is intended to assess chronic and/or acute compartmental syndrome, a condition of increased intra-compartmental pressures from swelling within muscle compartments and tendon sheaths due to trauma. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXC	Monitor, Pressure, Intracompartmental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K844214	000

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: 37023cab-ee38-4092-8305-beb5267c5290
Public Version Date: May 11, 2022
Public Version Number: 1
DI Record Publish Date: May 03, 2022