AccessGUDID - DEVICE: Bolus - US (17290109150038)

GUDID

Device Identifier (DI) Information

Brand Name: Bolus - US
Version or Model: 15071-000-0005
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 15071-000-0005
Company Name: EITAN MEDICAL LTD

Primary DI Number: 17290109150038
Issuing Agency: GS1
Commercial Distribution End Date: March 03, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 533108028 *Terms of Use

Device Description: No description.

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?
35465	Assistive remote control	An electronic device designed as a control panel/unit, which may include a receiver, intended to assist a person with a disability to control and operate other devices remotely in their local environment. It includes multiple buttons/switches to allow control of various functions and includes characteristics (button size, simplicity) to allow ease of use.	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: 7bb6789a-2e8d-4ca0-8bf3-f2b6ec4be929
Public Version Date: November 23, 2022
Public Version Number: 5
DI Record Publish Date: July 07, 2016