FDA UDI In Commercial Distribution 🇺🇸 United States

Acrobat-i Positioner

DI: 00607567500006 · Model: XP-5000Z · MAQUET CARDIOVASCULAR LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Acrobat-i Positioner
Primary DI
00607567500006
Version / Model
XP-5000Z
Catalog Number
XP-5000Z
Company Name
MAQUET CARDIOVASCULAR LLC
Labeler DUNS
022348156
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-04-27
Public Version
2
Public Version Date
2021-04-09
Public Version Status
Update
Public Device Record Key
b21c31d4-1dfb-4dbc-9e18-ad1d1dacd996

Device Description

Acrobat-i Vacuum Positioner System

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
MWS Stabilizer,Heart

GMDN Terms

Code Name
62493 Coronary artery exposure retractor

Identifiers

Type ID
Primary 00607567500006

Customer Contacts

Phone
888-880-2874