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FDA 510(k)

HEMOBAG, MODEL HBBSD2000

K-Number: K031150 · 2003-06-23

ApplicantGlobal Blood Resources, LLC
Decision Date2003-06-23
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEMOBAG, MODEL HBBSD2000 is the device name listed in this FDA 510(k) record. The listed applicant is Global Blood Resources, LLC. It received FDA 510(k) clearance on 2003-06-23 under 510(k) number K031150. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOBAG, MODEL HBBSD2000?

HEMOBAG, MODEL HBBSD2000 is a medical device that received FDA 510(k) clearance on 2003-06-23. The listed applicant is Global Blood Resources, LLC. The 510(k) number is K031150.

When did HEMOBAG, MODEL HBBSD2000 receive FDA 510(k) clearance?

HEMOBAG, MODEL HBBSD2000 received FDA 510(k) clearance on 2003-06-23, under 510(k) number K031150.

Who is the listed applicant for HEMOBAG, MODEL HBBSD2000?

The FDA 510(k) record lists Global Blood Resources, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOBAG, MODEL HBBSD2000?

The FDA product code for HEMOBAG, MODEL HBBSD2000 is DTN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Global Blood Resources, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K031151TS3 TUBING SET

Related Devices (Code: DTN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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