AccessGUDID - DEVICE: Provizio SEM250 (00860740002661)

GUDID

Device Identifier (DI) Information

Brand Name: Provizio SEM250
Version or Model: 02661
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bruin Biometrics, LLC

Primary DI Number: 00860740002661
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962732025 *Terms of Use

Device Description: Provizio SEM Scanner OEM Parts Kit

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?
63424	Localized oedema electrical impedance scanner	A hand-held electronic device designed to help diagnose localized oedema in subcutaneous tissue in the inflammatory phase, prior to visible skin symptoms. It is a portable noninvasive unit with a display screen and an electrode designed to scan a patient’s unbroken skin whereby low frequency electrical current is applied and detected to measure degree of bioimpedance as an indication of sub-epidermal moisture, a marker of pressure-induced tissue damage (e.g., pressure ulcer).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QEF	Pressure Ulcer Management Tool

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN170021	000

Device Exempt from Premarket Submission: No 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: ff1a8bdb-2871-4ae0-ab3d-8cfd07322f20
Public Version Date: January 03, 2024
Public Version Number: 2
DI Record Publish Date: June 28, 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: Yes
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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