AccessGUDID - DEVICE: Perfektum® (00816329021547)

GUDID

Device Identifier (DI) Information

Brand Name: Perfektum®
Version or Model: 5154
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5154
Company Name: CADENCE SCIENCE, INC.

Primary DI Number: 00816329021547
Issuing Agency: GS1
Commercial Distribution End Date: November 30, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 001618818 *Terms of Use

Device Description: Ecc Tip Match Num 50mL in 2mL, Lock Tip

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:	No
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?
62182	General-purpose syringe, reusable	A non-sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); it is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment of the female connector (hub) of a hypodermic needle or an administration set. It is typically made of glass and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, Piston

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 4d3cc372-6524-4fd3-b3e3-a5d664a68342
Public Version Date: February 27, 2020
Public Version Number: 4
DI Record Publish Date: September 20, 2016