GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET

K960511 · Gibeck, Inc. · DWJ · Jan 13, 1997 · Cardiovascular

Device Facts

Record IDK960511
Device NameGIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET
ApplicantGibeck, Inc.
Product CodeDWJ · Cardiovascular
Decision DateJan 13, 1997
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.5900
Device ClassClass 2
AttributesTherapeutic

Device Story

Thermal regulation system; convective warming blanket. Device connects to external warming unit to deliver heated air to patient. Used in clinical settings (OR/surgical) by healthcare professionals. Provides patient warming to maintain normothermia during procedures. Reusable design.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Reusable convective warming blanket; thermal regulation system per 21 CFR 870.5900. Materials and manufacturing processes differ from predicate but maintain equivalent function.

Indications for Use

Indicated for thermal regulation in patients requiring convective warming during therapeutic, prosthetic, or surgical procedures.

Regulatory Classification

Identification

A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0} JAN 13 1997 Gibeck K960511 Subject: 510(k) Summary of Safety and Effectiveness Product: Gibeck, Inc. Warmbag Reusable Convective Warming Blanket ## Summary: This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The Gibeck, Inc. Warmbag Reusable Convective Warming Blanket is a thermal regulation system as described in 21 CFR 870.5900. These products are substantially equivalent to the TropicAir Reusable Convective Warming Blankets distributed by Seabrook Medical, Inc. The Gibeck, Inc. Warmbag Reusable Convective Blanket is similar in design, operation and function to the Seabrook Medical, Inc. TropicAir Reusable Convective Warming Blanket. The principal differences between the Gibeck, Inc. Warmbag Reusable Convective Warming Blanket and the Seabrook Medical, Inc. TropicAir Reusable Convective Warming Blanket are the manufacturing processes, materials and labeling. These differences are not considered to be critical to the intended therapeutic, prosthetic or surgical use of the device nor should these differences significantly affect the safety or effectiveness of the device when used as labeled. ![img-0.jpeg](img-0.jpeg) ![img-1.jpeg](img-1.jpeg) Gibeck, Inc. 10640 East 59th Street • P.O. Box 36430 • Indianapolis, IN 46236 Telephone: (317) 823-6866 • Telefax: (317) 823-1662 A Member of the Gibeck Group
Innolitics
510(k) Summary
Decision Summary
Classification Order
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