AccessGUDID - DEVICE: Smart Caregiver (00812293011348)

GUDID

Device Identifier (DI) Information

Brand Name: Smart Caregiver
Version or Model: PGC-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Smart Caregiver Corporation

Primary DI Number: 00812293011348
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012082397 *Terms of Use

Device Description: Pager Case

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
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: 9831d8d5-9e5b-4a13-b22c-4b0ef3e345b8
Public Version Date: June 02, 2022
Public Version Number: 1
DI Record Publish Date: May 25, 2022

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

[?]

No Customer Contact currently defined

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