AccessGUDID - DEVICE: Infusion Safety Products, Inc. (00856673008184)

GUDID

Device Identifier (DI) Information

Brand Name: Infusion Safety Products, Inc.
Version or Model: ISP201Y
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INFUSION SAFETY PRODUCTS, INC.

Primary DI Number: 00856673008184
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024502047 *Terms of Use

Device Description: 20ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with a non-vented cap, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .35cc

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:	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?
17701	Vascular port administration set	A collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PTI	Non-Coring (Huber) Needle

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170881	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: 8651e136-7b7f-4c5d-8d0c-dba0ea23f68f
Public Version Date: February 26, 2020
Public Version Number: 3
DI Record Publish Date: July 20, 2018