AccessGUDID - DEVICE: Infinity (18148440000095)

GUDID

Device Identifier (DI) Information

Brand Name: Infinity
Version or Model: 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 50744
Company Name: ZEVEX INTERNATIONAL, INC.

Primary DI Number: 18148440000095
Issuing Agency: GS1
Commercial Distribution End Date: March 08, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 612746933 *Terms of Use

Device Description: Enteralite Infinity AC Adapter/charger

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
Prescription Use (Rx):	No
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?
36542	Voltage-converting power supply	A device, commonly known as a battery eliminator, designed to convert mains electrical current into the voltage required by a device. It typically supplies the electric power to and through the internal batteries of the device being supplied.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LZH	Pump, Infusion, Enteral

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: e6df5b9d-ccdb-4b93-8487-044e312eecf3
Public Version Date: May 07, 2021
Public Version Number: 2
DI Record Publish Date: August 03, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
38148440000099	5	18148440000095	2021-03-03	Not in Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800-970-2337
Email: medcustomerservice@moog.com

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