FDA UDI In Commercial Distribution 🇺🇸 United States

BE SMART GET PREPARED

DI: 00020424013608 · Model: 10COM01360; 10HBC01360 · TOTAL RESOURCES INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
BE SMART GET PREPARED
Primary DI
00020424013608
Version / Model
10COM01360; 10HBC01360
Company Name
TOTAL RESOURCES INTERNATIONAL INC.
Labeler DUNS
790160535
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-01-08
Public Version
1
Public Version Date
2024-01-16
Public Version Status
New
Public Device Record Key
32bf8757-c961-4335-95cb-632a5f5ac30a

Device Description

Be Smart Get Prepared, Tender Lovin’, Wound Care Kit, 70 Pieces – Diabetic Wounds, Pressure Ulcers, Chronic Wounds, Post-op, Lacerations, Home, Travel, Care Facilities -(8) Sterile Gauze Pads 4 in x 4 in / 4 ply [10.16 cm x 10.16 cm]; (8) Examination Gloves 4 pairs; (5) SILVEX Wound Gels 0.18 oz [5 g]; (5) Sheer Bandages [1 in x 3 in]; (3) Silicone Foam Dressings 2 in x 2 in [5.08 cm x 5.08 cm]; (2) Silicone Foam Dressings 4 in x 4 in [10.16 cm x 10.16 cm]; (2) Sterile Gauze Rolls 2 in x 147.60 in (4 yd 3.60 in) [5.08 cm x 3.75 m]; (1) Sterile Gauze Roll 4 in x 147.60 in (4 yd 3.60 in) [10.16 cm x 3.75 cm]; (1) Silicone Tape 1 in x 98.28 in (2 yd 2 ft) [2.54 cm x 2.51 m]; (24) Antiseptic Wipes; (9) Skin Lotions 0.03 oz [0.90 g]; (1) Scissors 3 1/2 in [8.89 cm]; (1) Advanced Wound Care Guide

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
Yes
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LRR First Aid Kit With Drug

GMDN Terms

Code Name
44039 First aid kit, medicated

Identifiers

Type ID
Primary 00020424013608