AccessGUDID - DEVICE: Amsco (00724995154103)

GUDID

Device Identifier (DI) Information

Brand Name: Amsco
Version or Model: DJ03012413112
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DJ03012413112
Company Name: STERIS CORPORATION

Primary DI Number: 00724995154103
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 036985604 *Terms of Use

Device Description: The AMSCO Warming Cabinet Premium Solid Single 24-inch 120V Electronic Door Locks Electronic Data Recording is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable Level.

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):	No
Over the Counter (OTC):	Yes
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?
45334	Multi-purpose warming cabinet, recessed	A mains electricity (AC-powered) built-in device designed to warm various items and products prior to use, e.g., bags of irrigation or intravenous (IV) solutions, blankets or clothing to cover or put onto a patient, or clothing for the operating room (OR) personnel to adorn. It typically consists of a heat insulated enclosure with a sealing door, shelves, heating element(s), a thermostat and operating controls. This is a cabinet that is built into the room construction (recessed into the wall) so that it does not take any floor space of, e.g., the OR. It may also be used in a laboratory.	Active	false
40516	Multi-purpose warming cabinet, stationary	A mains electricity (AC-powered) device designed to warm various items and products prior to use, e.g., bags of irrigation or intravenous (IV) solutions, blankets or clothing to cover or put onto a patient, or clothing for the operating room (OR) personnel to adorn. It typically consists of a heat insulated enclosure with a sealing door, shelves, heating element(s), a thermostat and operating controls. This is a freestanding cabinet (tabletop or floor design) that is designed to be stationary and used in one location. It may also be used in a laboratory.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6880b0bd-c12e-404e-bf73-15f131725ce2
Public Version Date: November 24, 2020
Public Version Number: 5
DI Record Publish Date: June 30, 2017