AccessGUDID - DEVICE: BIOS Living (00057475800314)

GUDID

Device Identifier (DI) Information

Brand Name: BIOS Living
Version or Model: 80031
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Thermor Ltd

Primary DI Number: 00057475800314
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 246883458 *Terms of Use

Device Description: Diabetic Sock LRG White/Black - 6 Pack (70032 x 3pcs / 70028 x 3pcs)

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?
58831	Antimicrobial sock	A tubular, fabric device intended to be worn on the feet of a patient to help maintain foot health and reduce the growth of fungi and bacteria through inclusion of an antimicrobial agent [e.g., pure cotton yarn containing silver (Ag) nanoparticles]. It is typically indicated for a patient who suffers from athlete’s foot, diabetic foot, neurological sensory disorders (e.g., unable to feel micro traumas, touch, or temperature), and impaired blood circulation; it is generally intended to reduce the risk of primary and secondary infection. The device is normally available for daily use in the home or healthcare facility. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQL	Stocking, Medical Support (For General Medical Purposes)

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: 512f9ccf-e879-4040-b8e8-9cb903f303e2
Public Version Date: November 15, 2023
Public Version Number: 1
DI Record Publish Date: November 07, 2023

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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