AccessGUDID - DEVICE: Sapphire Power Supply (fixed head) (17290109150182)

GUDID

Device Identifier (DI) Information

Brand Name: Sapphire Power Supply (fixed head)
Version or Model: 15072-000-0007-ASM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 15072-000-0007-ASM
Company Name: EITAN MEDICAL LTD

Primary DI Number: 17290109150182
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 533108028 *Terms of Use

Device Description: Sapphire Power Supply, USA type with metal ODU 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:	No
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?
36545	Basic power supply, reusable	A device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRZ	Accessories, Pump, Infusion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123049	000

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
Storage Environment Temperature: between -40 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fd62e77f-b674-44f9-b192-72a91faad8e9
Public Version Date: November 23, 2022
Public Version Number: 5
DI Record Publish Date: June 29, 2017