AccessGUDID - DEVICE: Infinity Spike Set with Enfit Connector (10814844001980)

GUDID

Device Identifier (DI) Information

Brand Name: Infinity Spike Set with Enfit Connector
Version or Model: INF0020-E
Commercial Distribution Status: In Commercial Distribution
Catalog Number: INF0020-E
Company Name: ZEVEX INTERNATIONAL, INC.

Primary DI Number: 10814844001980
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 612746933 *Terms of Use

Device Description: Infinity Spike Set with Enfit Connector

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?
11675	Enteral feeding bag/bottle	An empty pouch or bottle made of plastic or glass intended to contain a fluid of nutrients for administration to a patient through an enteral tube that provides direct access to the stomach, duodenum, or jejunum; it is not intended for intravenous (IV) administration. It may be composed of one or more chambers and might be provided with a short length of tubing; however, it does not include other associated items (e.g., clamp, spike) [i.e., not an enteral feeding set] and is not intended to be directly connected to the invasive feeding tube. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PIF	Gastrointestinal Tubes With Enteral Specific Connectors

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: No
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: 3ac26e0f-5de7-4760-aefe-696ac770edd7
Public Version Date: October 04, 2021
Public Version Number: 1
DI Record Publish Date: September 24, 2021