AccessGUDID - DEVICE: ARIAL (00840948103001)

GUDID

Device Identifier (DI) Information

Brand Name: ARIAL
Version or Model: 54745
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 54745
Company Name: Securitas Healthcare LLC

Primary DI Number: 00840948103001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079758354 *Terms of Use

Device Description: Apollo Gold AP900 Alphanumeric Pager, 464.6MHz.

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?
44341	Phone/pager	A telecommunication device intended to receive messages/calls from a nurse call or home alert system device (e.g., ambulatory fall sensor, wall-affixed push-button) to notify a recipient that (urgent) assistance is required by the patient; it is also used with some long-session therapeutic devices (e.g., cryolipolysis skin contouring system) to send reminders to the operator during treatment. It alerts the recipient with an audio, tactile, and/or visual signal and is typically used by medical professionals, caregivers or neighbours responsible for the patient.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IQA	System, Environmental Control, 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: b5040c9b-68d3-434c-b89a-3151bad77f8b
Public Version Date: June 21, 2024
Public Version Number: 1
DI Record Publish Date: June 13, 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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800) 380-8883
Email: Support_all@sbdinc.com

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