FDA UDI In Commercial Distribution 🇺🇸 United States

ARMEDICA

DI: B866MAMBAX54001 · Model: AMBAX5400 · ARMEDICA MANUFACTURING CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
ARMEDICA
Primary DI
B866MAMBAX54001
Version / Model
AMBAX5400
Catalog Number
AMBAX5400
Company Name
ARMEDICA MANUFACTURING CORP.
Labeler DUNS
018941711
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-11-18
Public Version
1
Public Version Date
2022-11-28
Public Version Status
New
Public Device Record Key
8c4ff64b-cc6f-4128-a720-040607ac8d7b

Device Description

STEEL, ELECTRIC, BAR ACTIVATED, X FRAME, THREE SECTION, 27 IN WIDE TREATMENT TABLE WITH ADJUSTABLE HEAD SECTION, CRESCENT ARMREST, ADJUSTABLE FOOT SECTION, AND CASTERS

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
Yes
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
INQ Table, Powered

GMDN Terms

Code Name
31362 Examination/treatment table, line-powered

Identifiers

Type ID
Primary B866MAMBAX54001
Package B866PAMBAX54001