FDA UDI In Commercial Distribution 🇺🇸 United States

CareOne

DI: 00041520126634 · Model: 041520126634 · Ahold U.S.A., Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
CareOne
Primary DI
00041520126634
Version / Model
041520126634
Company Name
Ahold U.S.A., Inc.
Labeler DUNS
170199058
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-09-27
Public Version
1
Public Version Date
2020-10-05
Public Version Status
New
Public Device Record Key
e518a6c7-eabd-4c36-9723-a489ed765988

Device Description

Wound Care Kit, 40 pieces: 10 - Gauze Pads 4 IN x 4 IN (101 mm x 101 mm); 10 - Antiseptic Wipes 4.75 IN x 7.75 IN (120 mm x 196 mm); ; 12 – Non-stick Pads 3 IN x 4 IN (76 mm x 101 mm); 4 – Transparent Dressings 2.36 IN x 2.75 IN (59 mm x 69 mm); 3 – Rolled Gauze 4 IN x 2.5 YD (101 mm x 2.28 m); 1 – Paper Tape 1 IN x 10 YD (25 mm x 9.14 m);

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
Yes
Combination Product
Yes
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LRR First Aid Kit With Drug

GMDN Terms

Code Name
44039 First aid kit, medicated

Identifiers

Type ID
Package 10041520126631
Primary 00041520126634

Customer Contacts