AccessGUDID - DEVICE: Steelco (08058341879757)

GUDID

Device Identifier (DI) Information

Brand Name: Steelco
Version or Model: BP 100 HSER
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BP 100 HSER
Company Name: STEELCO SPA

Primary DI Number: 08058341879757
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428717469 *Terms of Use

Device Description: This device is a multi-functional aid capable of holding all the receptacles commonly used in hospital, such as bedpans,urine bottle, suction bottle, bucket etc. With the use of a removable dedicated rack on slides, this device can be also for washing and disinfection (low intermediate) small objects.

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?
35318	Bedpan/ancillary utensil washer-disinfector (thermal)	An electrically-powered unit designed to both wash (remove organic debris, dirt, stains) and thermally disinfect (destroy microorganisms) reusable devices such as bedpans, urine bottles, suction bottles, emesis basins (kidney bowls), handwash basins and similar reusable devices. The device includes an internal chamber containing baskets/racks onto which the medical devices are placed to help maximize contact with all surfaces and parts. It is used in hospitals, long-term care facilities, nursing homes and healthcare centres.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLH	Washer Of Body Waste Receptacles

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: 82675acc-eeb5-40dc-8c89-c184766db2b8
Public Version Date: October 18, 2023
Public Version Number: 3
DI Record Publish Date: November 17, 2019