AccessGUDID - DEVICE: DeRoyal (00749756951180)

GUDID

Device Identifier (DI) Information

Brand Name: DeRoyal
Version or Model: M2300-NC12
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M2300-NC12
Company Name: DEROYAL INDUSTRIES, INC.

Primary DI Number: 00749756951180
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 096372255 *Terms of Use

Device Description: NURSE CALL CORD

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":	Yes
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?
41915	Medical device service rail system	An assembly of devices and components designed to provide a secure method of fixing/mounting/organizing medical/non-medical devices being used in the vicinity of the patient for treatment/care and to provide services. It is typically be used in hospital wards, treatment rooms or intensive care units (ICU) where there is a demand for built-in amenities (e.g., electricity, medical gases, nurse call system and/or intercom systems). It is fixed to the wall or built onto the wall. The rail will have a preformed cross-section incorporating a safety design compatible to the clamps and holders to be used with the rail to provide the mounting method. It is typically supplied in prefabricated units.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KMI	MONITOR, BED PATIENT

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: 597c49ea-50d6-46d6-a369-2deea3bd246d
Public Version Date: August 11, 2021
Public Version Number: 1
DI Record Publish Date: August 03, 2021

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: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

Phone: +1(888)938-7828
Email: udisupport@deroyal.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES