AccessGUDID - DEVICE: PASCAL (00690103216981)

GUDID

Device Identifier (DI) Information

Brand Name: PASCAL
Version or Model: 10000T
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10000TA
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103216981
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: PASCAL TABLE US COMMERCIAL

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:	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?
63543	Cardiac implantation catheter table	A non-sterile, noninvasive device designed to provide a flat surface to support the holder of a cardiac implant delivery catheter during delivery of a cardiac implant. It is typically a height-adjustable device with legs that is placed on an operating table. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NKM	Mitral Valve Repair Devices

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P220003	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
No Device Sizes

Device Record Status

Public Device Record Key: d5e382c8-8812-46b1-9343-4268a8d8336e
Public Version Date: September 27, 2022
Public Version Number: 1
DI Record Publish Date: September 19, 2022

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: No Unit of Use DI Numbers Found 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: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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