AccessGUDID - DEVICE: HeartLight (00868976000130)

GUDID

Device Identifier (DI) Information

Brand Name: HeartLight
Version or Model: 18-1342
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 18-1342
Company Name: CARDIOFOCUS, INC.

Primary DI Number: 00868976000130
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 068966261 *Terms of Use

Device Description: Balloon Fill Media

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?
61970	Vascular balloon catheter fill-media	A dedicated sterile solution (e.g., deuterium oxide) intended to be pumped into an appropriate vascular balloon catheter (e.g., cardiac laser system beam guide-catheter with balloon tip) to inflate the distal balloon during a vascular procedure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAE	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P150026	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: No direct sunlight
Storage Environment Temperature: between 0 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 95 Milliliter

Device Record Status

Public Device Record Key: 70f44d2c-d4ed-48c9-8cda-4d88faaa68e5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 15, 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: 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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(844)527-3723
Email: customerservice@cardiofocus.com

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