AccessGUDID - DEVICE: simpleABI (00852785008609)

GUDID

Device Identifier (DI) Information

Brand Name: simpleABI
Version or Model: ABI-600CL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ABI-600CL
Company Name: NEWMAN MEDICAL LLC

Primary DI Number: 00852785008609
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078686903 *Terms of Use

Device Description: ABI-600CL Software, 8 port Cuff-Link w remote, 8MHz Doppler probe, PPG, 2x10cm cuffs, 4x12cm cuffs, 2x12cm long cuffs, 2x2.5cm disposable digit cuffs, roll stand, user manual, quick reference guides.

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?
44311	Noninvasive vascular ultrasound system	An electrically-powered device assembly consisting of a control unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular (venous and arterial) flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. It may also be used to detect the foetal heartbeat.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAF	Monitor, Ultrasonic, Nonfetal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110628	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 Humidity: between 5 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 50 Degrees Celsius
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bc1e35a1-41a0-4f31-84de-da90b6c4f522
Public Version Date: November 03, 2023
Public Version Number: 2
DI Record Publish Date: June 08, 2018