AccessGUDID - DEVICE: HeartLight (00868976000123)

GUDID

Device Identifier (DI) Information

Brand Name: HeartLight
Version or Model: 18-1447
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 18-1447
Company Name: CARDIOFOCUS, INC.

Primary DI Number: 00868976000123
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 068966261 *Terms of Use

Device Description: Endoscope

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?
34855	Flexible fibreoptic arterioscope, reusable	An endoscope with a very thin, flexible inserted portion intended for the visual examination and some treatment of coronary arteries, peripheral vessels, and intracardiac structures. It is inserted into the body through a surgically-created orifice during arterioscopy. Anatomical images are transmitted to the user through a fibreoptic bundle (e.g., a fused silica flexible rod that provides sharper images and greater strength). This device is intended to be used to examine arteries and arterial circulation; blood flow is normally blocked in the arteries by a balloon while a clear liquid is infused to flush away residual blood to provide a clear view. This is a reusable 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 [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c2ffcece-aa89-407a-9933-a436c86c9bfa
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: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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