AccessGUDID - DEVICE: ASTOFLO® PLUS ECO (04260114140702)

GUDID

Device Identifier (DI) Information

Brand Name: ASTOFLO® PLUS ECO
Version or Model: WP34
Commercial Distribution Status: In Commercial Distribution
Catalog Number: WP34
Company Name: Stihler Electronic GmbH

Primary DI Number: 04260114140702
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317742377 *Terms of Use

Device Description: Heating profile

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:	No
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Conduction blood/fluid warmer	A mains electricity (AC-powered) device, which may include rechargeable batteries, designed for in-line heating of banked blood, blood products, intravenous (IV) solutions, and irrigation fluids, typically from about 4ºC to near body temperature (i.e., 35 to 37ºC) before infusion, through the conduction of heat. The device usually includes a surface heat exchanger (e.g., heated dry plate) for the conduction of heat to the infusion blood/fluid via a disposable set (e.g., tubing or pouch); it also includes temperature controls and/or alarms. It is typically mounted on an IV pole under the infusion bag; it does not infuse blood/fluid.

GMDN Preferred Term Name

GMDN Definition

Conduction blood/fluid warmer

A mains electricity (AC-powered) device, which may include rechargeable batteries, designed for in-line heating of banked blood, blood products, intravenous (IV) solutions, and irrigation fluids, typically from about 4ºC to near body temperature (i.e., 35 to 37ºC) before infusion, through the conduction of heat. The device usually includes a surface heat exchanger (e.g., heated dry plate) for the conduction of heat to the infusion blood/fluid via a disposable set (e.g., tubing or pouch); it also includes temperature controls and/or alarms. It is typically mounted on an IV pole under the infusion bag; it does not infuse blood/fluid.

FDA Product Code

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Product Code	Product Code Name
LGZ	Warmer, thermal, infusion fluid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082765	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c387f684-6ae4-4ca3-a888-d674810f1953
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 07, 2016