Model: DDS1159C
Catalog: DDS1159C
DI: B098DDS1159C0
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
Heart Cath Tray - RX
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d067a77f-f551-4f52-acd5-b0103f4c4158
Distribution Status:
In Commercial Distribution
DUNS Number:
106580145
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
Combination Product:
Yes
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Case
Item #1 - Device ID:
B098DDS1159C1
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
4
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
B098DDS1159C0
Item #1 - Device ID Issuing Agency:
HIBCC
Item #2 - Device ID:
B098DDS1159C0
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
HIBCC
GMDN
Code: 46408
Name: Cardiothoracic surgical procedure kit, medicated, single-use
Definition:
A collection of various sterile cardiothoracic surgical instruments, dressings, and materials including a pharmaceutical component, intended to be used to assist a range of cardiothoracic surgical procedures. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This is a single-use device intended to be sterilized prior to use.
FDA Product Codes
OES
Cardiac Catheterization Kit
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
20
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
25
Storage Handling - Storage Handling Type:
Storage Environment Temperature