AccessGUDID - DEVICE: SHOWER & DISINFECTION PANEL (05055982707954)

GUDID

Device Identifier (DI) Information

Brand Name: SHOWER & DISINFECTION PANEL
Version or Model: BCA1224-04
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BCA1224-04
Company Name: Arjohuntleigh AB

Primary DI Number: 05055982707954
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 355804758 *Terms of Use

Device Description: SHOWER & DISINFECTION PANEL, WHITE, US, with FLUSH VALVE

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?
44116	Shower unit	An electrically-powered device intended to deliver a pressurized stream of water for cleaning/washing patients or devices. It may include a function to mix a disinfectant with water prior to delivery. It may also include additional devices for seating a patient and/or collection of discharged water (e.g., sink).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILS	Adaptor, Hygiene

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: 823c9bba-0a9e-48cc-8eef-29f33dcbed24
Public Version Date: May 30, 2024
Public Version Number: 1
DI Record Publish Date: May 22, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1(800) 323-1245
Email: us.info@arjo.com

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