AccessGUDID - DEVICE: CARDIOTOMY RESERVOIR (08033178109673)

GUDID

Device Identifier (DI) Information

Brand Name: CARDIOTOMY RESERVOIR
Version or Model: UNFILTERED
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SORIN GROUP ITALIA SRL

Primary DI Number: 08033178109673
Issuing Agency: GS1
Commercial Distribution End Date: June 15, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 442126587 *Terms of Use

Device Description: No description.

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?
31710	Cardiotomy reservoir	A device intended to be integrated within an extracorporeal circuit to collect, store, and filter blood typically during a cardiopulmonary bypass procedure; it does not include additional functional components such as an oxygenator. It is typically a hardshell or soft, bag-like container with connectors designed to trap micro-particles and air bubbles for a period of time (e.g., 6 hours) and hold a reserve supply of blood; some types may also defoam. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTP	Defoamer, cardiopulmonary bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K902437	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5446c448-01b2-4ec9-8a7d-c5ce03efd49e
Public Version Date: July 02, 2026
Public Version Number: 5
DI Record Publish Date: July 15, 2015