AccessGUDID - DEVICE: ACUMEN IQ SENSOR FOR AFM (00690103201062)

GUDID

Device Identifier (DI) Information

Brand Name: ACUMEN IQ SENSOR FOR AFM
Version or Model: AIQSAFM8R5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AIQSAFM8R5
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103201062
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: ACUMEN IQ 84" / 213CM FOR USE WITH ASSISTED FLUID MANAGEMENT SOFTWARE FEATURE RED CAP FIVE PACK

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
35927	Invasive-pressure external transducer, single-use	A sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRS	Transducer, Blood-Pressure, Extravascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152980	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: STORE IN A COOL, DRY PLACE

Clinically Relevant Size

[?]

Size Type Text
Length: 84.0000 Inch

Device Record Status

Public Device Record Key: d7bfca10-57ab-4d6c-92f9-58385c6e2bb8
Public Version Date: July 17, 2019
Public Version Number: 1
DI Record Publish Date: July 09, 2019