FDA UDI In Commercial Distribution 🇺🇸 United States

DARCO® AirTraveler™ Walker

DI: 00609271989054 · Model: AT0 · DARCO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
DARCO® AirTraveler™ Walker
Primary DI
00609271989054
Version / Model
AT0
Catalog Number
AT0
Company Name
DARCO INTERNATIONAL, INC.
Labeler DUNS
184231298
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-02-08
Public Version
1
Public Version Date
2023-02-16
Public Version Status
New
Public Device Record Key
84e48dc6-e89b-4332-bae8-2abf0d9123e8

Device Description

XS Black High version

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FZF SPLINT, EXTREMITY, INFLATABLE, EXTERNAL

GMDN Terms

Code Name
32302 Inflatable extremity splint

Identifiers

Type ID
Package 10609271989051
Primary 00609271989054
Package 20609271989058