AccessGUDID - DEVICE: ANSI First Aid Kit Class B+, 250 Person (10850015055321)

GUDID

Device Identifier (DI) Information

Brand Name: ANSI First Aid Kit Class B+, 250 Person
Version or Model: H-9997
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ULINE, INC.

Primary DI Number: 10850015055321
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039612668 *Terms of Use

Device Description: ABSORBENT COMPRESS, ANTACID, ANTIBIOTIC OINTMENT, ANTISEPTIC TOWELETTE, ASPIRIN, BLOODBORNE PATHOGEN KIT, BURN DRESSING, COHESIVE ELASTIC BANDAGE, COTTON SWAB, COUGH DROPS, CPROTECTOR, EMERGENCY RESCUE BLANKET, EXTRA-STRENGTH ACETAMINOPHEN, EYE PAD WITH TAPE, FABRIC BANDAGE, FABRIC FINGERTIP BANDAGE, FABRIC KNUCKLE BANDAGE, FIRST AID/BURN CREAM, FIRST AID FACTS GUIDE, FIRST AID TAPE, GAUZE PAD, GAUZE ROLL, GAUZE ROLL, HAND SANITIZER, IBUPROFEN, INSTANT ICE PACK, NITRILE GLOVE, NON-STICK PAD, PLASTIC BANDAGE, PLASTIC BANDAGE, PLASTIC BANDAGE, PLASTIC TWEEZERS, SPLINT, SCISSORS, SINGLE USE SALINE, STING WIPE, TOURNIQUET, TRAUMA DRESSING, TRIANGULAR BANDAGE, WOUNDSEAL TOPICAL POWDER

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: 3d19f601-aa2a-48a7-a5f3-c6625768b114
Public Version Date: June 17, 2024
Public Version Number: 4
DI Record Publish Date: March 22, 2022