AccessGUDID - DEVICE: EV1000 (00690103193626)

GUDID

Device Identifier (DI) Information

Brand Name: EV1000
Version or Model: PC2CCC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PC2CCC
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103193626
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: PRESSURE CONTROLLER CUFF CONNECTOR CAP

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?
43970	Cable/lead/sensor/probe cover, sterile	A sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier so that the non-sterile contents may enter a hygienic area, e.g., a sterile surgical field. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DSB	PLETHYSMOGRAPH, IMPEDANCE
DXN	SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140312	000
K160552	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
Special Storage Condition, Specify: STORE IN A COOL, DRY PLACE.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: SIZED FOR USE WITH THE EDWARDS EV1000 NI PRESSURE CONTROLLER (MODEL PC)

Device Record Status

Public Device Record Key: a4d29507-3a32-44ef-90a3-190240701ca2
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 03, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 70690103193625 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: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)822-9637
Email: tech_support@edwards.com

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