AccessGUDID - DEVICE: H-E-B (00041220216789)

GUDID

Device Identifier (DI) Information

Brand Name: H-E-B
Version or Model: 041220216789
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: H. E. BUTT GROCERY COMPANY

Primary DI Number: 00041220216789
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007924756 *Terms of Use

Device Description: All-Purpose First Aid Kit, 200 items: 40 - Sheer Bandages 5/8 IN x 2 1/4 IN (15 mm x 57 mm); 40 - Sheer Bandages 3/4 IN x 3 IN (19 mm x 76 mm); 20 - Sheer Spot Bandages 7/8 IN (22 mm); 16 - Fabric Bandages 5/8 IN x 2 1/4 IN (15 mm x 57 mm); 16 - Fabric Bandages 3/4 IN x 3 IN (19 mm x 76 mm); 10 - Waterproof Bandages 3/4 IN x 2 IN (19 mm x 50 mm); 12 - Antiseptic Wipes 4 3/4 IN x 7 3/4 IN (120 mm x 196 mm); 10 - Alcohol Prep Pad 1 3/16 IN x 2 5/16 IN (30 mm x 58 mm); 5 - Hydrocortisone cream 1/32 OZ (0.9 g); 8 - Triple Antibiotic Ointments 1/32 OZ (0.9 g); 2 - Wooden Finger Splints; 1 - Pair of metal scissors; 1 - pair of metal tweezers; 2 - Paper Tape 1/2 IN x 5 YD (12 mm x 4.5 m); 1 - Single Use Instant Cold Pack; 6 - Gauze Pads 2 IN x 2 IN (50 mm x 50 mm); 2 - Gauze Pads 4 IN x 4 IN (101 mm x 101 mm); 5 - Non-stick Pads 2 IN x 3 IN (50 mm x 76 mm); 2 - Rolled Gauze 2 IN x 2.5 YDS (50 mm x 2.28 m); 1 - Carrying Case

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":	Yes
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: 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: c8244fee-2bb6-4982-8811-73bd9d4c12c1
Public Version Date: August 19, 2024
Public Version Number: 4
DI Record Publish Date: April 29, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20041220216783	3	00041220216789	2022-08-24	Not in Commercial Distribution	case
10041220216786	6	00041220216789		In Commercial Distribution	Case
50041220216784	9	00041220216789		In Commercial Distribution	case