FDA UDI In Commercial Distribution 🇺🇸 United States

Probasics

DI: 00815067013357 · Model: X1WC4DAM23 · COMPASS HEALTH BRANDS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Probasics
Primary DI
00815067013357
Version / Model
X1WC4DAM23
Company Name
COMPASS HEALTH BRANDS CORP.
Labeler DUNS
827221698
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-06-10
Public Version
1
Public Version Date
2025-06-18
Public Version Status
New
Public Device Record Key
37591f6f-1036-4ded-82de-bdc60d3a1e62

Device Description

K4 Deluxe 18" Seat Extender w/ Seat Tube and Hardware

Device Characteristics

Single Use
No
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
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KNO Accessories, Wheelchair

GMDN Terms

Code Name
41512 Push-rim manual wheelchair, non-bariatric

Identifiers

Type ID
Primary 00815067013357

Customer Contacts

Phone
8003767263