AccessGUDID - DEVICE: Curaplex (00817617023885)

GUDID

Device Identifier (DI) Information

Brand Name: Curaplex
Version or Model: 15-10411NEG
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 15-10411NEG
Company Name: BOUND TREE MEDICAL, LLC

Primary DI Number: 00817617023885
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070556204 *Terms of Use

Device Description: Curaplex IV Admin Set, 15 Drop, 89 in, 1 LL Site, 1 PP Site, removable 6 in Ext Set w/Pinch Clamp, Spin Lock Connection

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?
12170	Intravenous administration tubing extension set	A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LHI	Set, i.V. Fluid transfer

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: Yes

Sterilization Method [?]
Ethylene Oxide

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: b719422d-06bc-46c8-91a2-4992f8d3b490
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: April 18, 2017