HeartSee Cardiac PET Processing Software 001771

GUDID 30815112020584

Image segmentation application software

Primary Device ID	30815112020584
NIH Device Record Key	aceeea7d-615d-41c2-b12f-889ebf09f3bb
Commercial Distribution Status	In Commercial Distribution
Brand Name	HeartSee Cardiac PET Processing Software
Version Model Number	1.00
Catalog Number	001771
Company DUNS	849234661
Company Name	Bracco Diagnostics Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	30815112020584 [Primary]

KPS	System, Tomography, Computed, Emission

Steralize Prior To Use	false
Device Is Sterile	false

00815112021535 - Junior Flexi Tip Pediatric Enema Tip	2025-06-09 Junior Flexi Tip
10815112021556 - SaftiCuff DK	2025-06-09 Safticuff DL Airway
10815112021563 - Super XL Enema System	2025-06-09 SXL w/Att. (Silicone Cuff)
30815112021581 - Enema Kit: Empty Enema Bag Delivery System	2025-06-09 Empty Snap Cap Bag
10815112021594 - EXACTA l Screw Cap Bag: Empty Enema Bag Delivery System	2025-06-09 Empty Exacta l Bag
10815112021624 - 24 Fr Infant Flexi Tip: Pediatric Enema Tip	2025-06-09 Infant Flexi Tip
30815112021635 - Miller Enema Air Tip: Without Retention Cuff	2025-06-09 Miller Air Tip
00815112021641 - 14 French Pediatric Flexi Tip	2025-06-09 14 Fr Pediatric Flexi Tip