AccessGUDID - DEVICE: Steelco (08051520020667)

GUDID

Device Identifier (DI) Information

Brand Name: Steelco
Version or Model: AD 400/2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AD 400/2
Company Name: STEELCO SPA

Primary DI Number: 08051520020667
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428717469 *Terms of Use

Device Description: This device drying cabinet provides fast drying of instruments, equipment and general items. It has dedicated connections allowing forced drying of anesthetic instruments.

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):	No
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?
17449	Breathing circuit dryer, closed	An electrically-powered cabinet designed to dry the interior of breathing circuit equipment (e.g., hoses, bags, masks) after washing, to prevent bacterial growth and equipment deterioration. The cabinet is designed to operate with closed doors, but may operate with open doors.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JRJ	Unit, Drying

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 9a12cec5-d97a-4da7-8daa-33fc1a38456f
Public Version Date: April 01, 2025
Public Version Number: 1
DI Record Publish Date: March 24, 2025