AccessGUDID - DEVICE: CareOne (00041520078438)

GUDID

Device Identifier (DI) Information

Brand Name: CareOne
Version or Model: 041520078438
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ahold U.S.A., Inc.

Primary DI Number: 00041520078438
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 170199058 *Terms of Use

Device Description: All-Purpose First Aid Kit, 125 items + 1 carrying case: 4 – Triple Antibiotic Ointment 1/32 OZ (0.9 g); 2 - Nitrile Gloves; 5 - Hand Cleansing Wipes 4 3/4 IN x 7 3/4 IN (120 mm x 196 mm); 1 – Paper Tape 1/2 IN x 5 YD (12 mm x 4.5 m); 14 - Sterile Pads 2 IN x 2 IN (50 mm x 50 mm); 6 – Non-stick Pads 2 IN x 3 IN (50 mm x 76 mm); 1 – Instant Cold Pack; 1 - Set of Tweezers; 10 - Butterfly Closures 1 3/4 IN x 3/8 IN (44 mm x 9 mm); 40 – Sheer Antibacterial Bandages 5/8 IN x 2 1/4 IN (15 mm x 57 mm); 30 - Sheer Antibacterial Bandages 3/4 IN x 3 IN (19 mm x 76 mm); Sheer Antibacterial Bandages 1 IN x 3 IN (25 mm x 76 mm); 1 - First Aid Guide; 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: ce898b73-62a8-4afa-8aac-63785bdaa899
Public Version Date: September 13, 2023
Public Version Number: 4
DI Record Publish Date: August 30, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
10041520078435	24	00041520078438	In Commercial Distribution	case
20041520078432	6	00041520078438	In Commercial Distribution	case
30041520078439	6	00041520078438	In Commercial Distribution	case