AccessGUDID - DEVICE: Syringe, 3cc (10850007350045)

GUDID

Device Identifier (DI) Information

Brand Name: Syringe, 3cc
Version or Model: 0295-005-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: C2DX, INC.

Primary DI Number: 10850007350045
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 116981210 *Terms of Use

Device Description: Syringe, 3cc, sodium chloride injection USP 0.9% (10/pkg)

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: 9cea9f38-7e88-4625-9059-0a95502caaa8
Public Version Date: May 10, 2021
Public Version Number: 2
DI Record Publish Date: April 08, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00850007350048 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 888-902-2239
Email: c2dx@c2dxinc.com

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