AccessGUDID - DEVICE: Uline First Aid Kit - 250 Person (10851253007639)

GUDID

Device Identifier (DI) Information

Brand Name: Uline First Aid Kit - 250 Person
Version or Model: H-3795
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H-3795
Company Name: ULINE, INC.

Primary DI Number: 10851253007639
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039612668 *Terms of Use

Device Description: ABSORBENT COMPRESS, ALCOHOL PREP PAD, ANTACID (2/PACKAGE), ANTIBIOTIC OINTMENT, ANTISEPTIC TOWELETTE, ASPIRIN (2/PACKAGE), BURN CREAM, COTTON SWABS, CPR MASK, ELASTIC BANDAGE, EXTRA-STRENGTH ACETAMINOPHEN (2/PACKAGE), EYE PAD, FABRIC BANDAGE, FABRIC FINGERTIP BANDAGE, FABRIC KNUCKLE BANDAGE, FIRST AID FACTS GUIDE, FIRST AID TAPE, PLASTIC TWEEZERS, GAUZE PAD - 2 X 2", GAUZE PAD - 3 X 3", GAUZE ROLL, IBUPROFEN (2/PACKAGE), INSTANT ICE PACK, NITRILE GLOVE, NON-STICK PADS, PLASTIC BANDAGE, SCISSORS, SINGLE USE SALINE, SINUS AND CONGESTION (2/PACKAGE), STING WIPES, TRIANGULAR BANDAGE

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?
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
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: 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: 7eb414e6-1c3e-4488-8ae7-aa89abe52dce
Public Version Date: May 03, 2024
Public Version Number: 14
DI Record Publish Date: January 18, 2019