AccessGUDID - DEVICE: PASCAL (00690103216974)

GUDID

Device Identifier (DI) Information

Brand Name: PASCAL
Version or Model: 20000ST
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20000STA
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103216974
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: PASCAL SYSTEM - STABILIZER RAIL SYSTEM

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?
63542	Cardiac implantation catheter holder, single-use	A noninvasive device designed to externally support a cardiac implant delivery catheter to secure and position the catheter during delivery of a cardiac implant. It is fixed onto a dedicated catheter platform and is typically a metallic or plastic structure with slots for fixing the catheter. It may be provided with additional supporting devices (e.g., the dedicated catheter platform and platform base). 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: 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
No Device Sizes

Device Record Status

Public Device Record Key: d864de32-6128-4965-8890-5a1a0aec2100
Public Version Date: June 30, 2025
Public Version Number: 2
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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