AccessGUDID - DEVICE: Derma Therapy (00857268006912)

GUDID

Device Identifier (DI) Information

Brand Name: Derma Therapy
Version or Model: DT-MCM-4880P-EA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: JOERNS HEALTHCARE, LLC

Primary DI Number: 00857268006912
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790937150 *Terms of Use

Device Description: DermaTherapy MED Linen;FIT 42-48X80-EA

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?
62028	Antimicrobial bed linen set	A collection of non-sterile devices including, but not limited to, a bed sheet(s), pillowcase, duvet cover and mattress cover, intended to be used to provide cover/protection to a bed and associated items. The components are treated/impregnated with an antimicrobial substance to control bacterial and fungal growth on the fabric and reduce the levels of house dust mites (HDM) and their allergen-containing faecal droppings. The device is typically made of a thin-textile or reinforced-paper material, to be used in the home or healthcare facility. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMW	Cover, Mattress (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: a498083f-2115-497b-80c0-29cfeb956921
Public Version Date: June 04, 2020
Public Version Number: 1
DI Record Publish Date: May 27, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20857268006916	12	00857268006912		In Commercial Distribution	Case

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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