AccessGUDID - DEVICE: NaviCare® Nurse Call Systems (00887761001541)

GUDID

Device Identifier (DI) Information

Brand Name: NaviCare® Nurse Call Systems
Version or Model: 3.6
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HILL-ROM, INC.

Primary DI Number: 00887761001541
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118106454 *Terms of Use

Device Description: Hospital Paging System

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?
18007	Personal paging system	An assembly of electronic communication devices installed throughout a building complex, e.g, a hospital or an institution, designed to page (summon) the individual persons who have been allotted the system receivers (the pagers) which are carried upon their person allowing them to ambulate from their normal workplace or station and still remain available for communication between a person needing to communicate with them. The system typically consists of strategically situated transmitters and individually distributed receivers (the pagers). Some types may include an integrated intercom system for direct verbal communication.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILQ	System, communication, powered

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: aa8fb9c6-ba51-4ce4-becb-f988809dcde1
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 17, 2016

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: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)445-3730
Email: us.customerservice@hill-rom.com

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

FDA TOOLS & RESOURCES