AccessGUDID - DEVICE: Smart Caregiver (00812293011737)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 00812293011737
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012082397 *Terms of Use

Device Description: Infrared Sensor

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?
65797	Inpatient motion surveillance unit	An electrically-powered device designed to be used in a healthcare or assisted living setting to track the movements of an inpatient/resident for capture of high-risk behaviour (e.g., bedridden patient bed vacation attempt, fall risk) and to automatically send alert notifications to healthcare staff via a central monitoring station. It includes one or more cameras and a processing unit intended to detect, record, and transmit high-risk events based on predetermined motion threshold references.	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: ebed6d99-1835-4994-8fe0-d7b31f0b3158
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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