AccessGUDID - DEVICE: Ozark Trail Outdoor Equipment (00017276235876)

GUDID

Device Identifier (DI) Information

Brand Name: Ozark Trail Outdoor Equipment
Version or Model: 017276235876
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: WAL-MART STORES, INC.

Primary DI Number: 00017276235876
Issuing Agency: GS1
Commercial Distribution End Date: January 25, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 051957769 *Terms of Use

Device Description: Burn Care First Aid Kit, 8 pieces: 1- Triple Antibiotic Ointments 1/32 OZ (0.9 g); 1 – First Aid & Burn Cream 1/32 OZ (0.9 g); 2 - 2 – Gauze Pads 2 IN x 2 IN (50 mm x 50 mm); 1- Carrying Case; 1 - Hydrogel Burn Pad 1.96 IN x 2.96 IN (49 mm x 74 mm); 1 - Paper Tape 1/2 IN x 5 YDS (12.7 mm x 4.5 m); 1 - Non-Stick Pad 2 IN x 3 IN (50 mm x 76 mm)

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:	Yes
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
OJI	Burn 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: a50b034a-2149-450d-b4d8-0354f922dce3
Public Version Date: August 16, 2021
Public Version Number: 2
DI Record Publish Date: December 16, 2019