AccessGUDID - DEVICE: Redicare (B70901020700)

GUDID

Device Identifier (DI) Information

Brand Name: Redicare
Version or Model: Burn Kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0102070
Company Name: REDICARE LLC

Primary DI Number: B70901020700
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 800149346 *Terms of Use

Device Description: First Aid Kit intended for treating minor & moderate burns in the workplace. Managed First Aid.

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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?
64420	Burn kit, medicated	A collection of devices designed to treat first or second degree burns typically as first aid therapy by emergency medical services (EMS); it includes pharmaceuticals (e.g., topical analgesic, antibiotic). It typically includes burn dressings, burn gels, gauze, cold packs, adhesive tapes, and gloves; it may include additional devices such as scissors and masks. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRR	First Aid Kit With Drug

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: 3a2bdc08-aa79-4eb8-b360-0729d6ef090e
Public Version Date: August 05, 2020
Public Version Number: 1
DI Record Publish Date: July 28, 2020