# K031150: Hemobag, Model HBBSD2000

- Pathway: 510(k) (Traditional)
- Applicant: Global Blood Resources, LLC
- Decided: Jun 23, 2003 after 74 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The HEMOBAGTM is a blood circulating storage reservoir designed to collect anticoagulated whole blood salvaged from extracorporeal circuits after the patient has been disconnected from the circuit. When used in connection with the TS3 Tubing Set and a commercially available hemoconcentrator, the HEMOBAGTM serves as a reservoir for circulating and hemoconcentrating blood in a closed circuit recovery loop.

Source page: https://510kreport.com/device/K031150
Methodology: https://510kreport.com/methodology