AccessGUDID - DEVICE: PremierPro (00818566016997)

GUDID

Device Identifier (DI) Information

Brand Name: PremierPro
Version or Model: 7223
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SVS LLC

Primary DI Number: 00818566016997
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 831375089 *Terms of Use

Device Description: Central Line Kit - Tegaderm 1655, Biopatch CHG disc, 4x4 Gauze, ChloraPrep 3m w/Insert, 3M Swabstick, Triple Swabstick Alcohol, Tape Strip, Tape Measure 24", Drape 13" x 18", Med Nitrile PF Blue Glove

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
61594	Central venous catheterization kit, short-term	A collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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: 8a50323e-a912-4175-93a0-e9f4aece0a91
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: October 12, 2016