AccessGUDID - DEVICE: L.H. Dottie (00781002848950)

GUDID

Device Identifier (DI) Information

Brand Name: L.H. Dottie
Version or Model: 16DOT01405CS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TOTAL RESOURCES INTERNATIONAL INC.

Primary DI Number: 00781002848950
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790160535 *Terms of Use

Device Description: FIRST + AID OSHA ANSI/ISEA 50-Person Kit, 251 Pieces –– by L.H. Dottie – (2) SILVEX® Wound Gels 0.18 oz; (24) Alcohol Prep Pads; (21) Antiseptic Wipes; (10) Aspirin Tablets; (10) Non-Aspirin Tablets; (8) Antacid Tablets; (6) Antibiotic Ointments; (6) Burn Creams; (3) Sting Relief Wipes; (2) Instant Cold Compress; (10) Safety Pins; (10) Cotton Tip Applicators; (5) Wood Splints; (4) Examination Gloves 2 pairs; (1) Paper Tape; (1) First Aid Guide OSHA/ANSI; (1) Tweezers; (1) Scissors; (40) Sheer Bandages 3/4 in x 3 in [1.91 cm x 7.62 cm]; (30) Sheer Bandages 3/8 in x 1 1/2 in [0.95 cm x 3.81 cm]; (20) Sheer Bandages 1 in 3 in [2.54 cm x 7.62 cm]; (11) Sterile Gauze Pads 4 in x 4 in/4 ply [10.16 cm x 10.16 cm]; (10) Sterile Gauze Pads 2 in x 2 in/4 ply [5.08 cm x 5.08 cm]; (5) Fabric Knuckle Bandages 1 1/2 in x 3 in [3.81 cm x 7.62 cm]; (5) Butterfly Closures; (2) Eye Pads; (1) Sterile Trauma Pad 5 in x 9 in [12.70 cm x 22.86 cm]; (1) Triangular Bandage w/ Safety Pins 40 in (1 yd 4 in) x 40 in (1 yd 4 in) x 56 in (1 yd 1 ft 8 in) [1.02 m x 1.02 m x 1.42 m]; (1) Gauze Roll 2 in x 148 in (4 yd 1/3 ft) [5.08 cm x 3.76 m]

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
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?
44039	First aid kit, medicated	A convenient collection of equipment, materials and pharmaceuticals intended to be used in an emergency for the rapid, initial treatment of an injury. It is typically used by emergency medical services (EMS), hospitals, institutions, schools, and other public settings. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: 42652b15-b0a8-4d19-af8f-6ab801ff3ef3
Public Version Date: March 05, 2025
Public Version Number: 1
DI Record Publish Date: February 25, 2025