AccessGUDID - DEVICE: Eclipse PRP HC (00853602008307)

GUDID

Device Identifier (DI) Information

Brand Name: Eclipse PRP HC
Version or Model: PRP2700-LLA
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PRP2700-LLA
Company Name: ECLIPSE

Primary DI Number: 00853602008307
Issuing Agency: GS1
Commercial Distribution End Date: November 05, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 969752364 *Terms of Use

Device Description: 22ml Blood Draw Supply Kit (No Female-Female Adapter)

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?
58497	Blood collection set, invasive	A collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. 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
Weight: 17.000 Gram
Depth: 1.250 Inch
Width: 3.000 Inch
Height: 6.750 Inch

Device Record Status

Public Device Record Key: 6dd47114-1305-4747-ba85-e8d013731f29
Public Version Date: April 07, 2021
Public Version Number: 3
DI Record Publish Date: October 04, 2018