FDA UDI In Commercial Distribution 🇺🇸 United States

N/A

DI: 04961333240753 · Model: 67061 · PENTAX OF AMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
N/A
Primary DI
04961333240753
Version / Model
67061
Company Name
PENTAX OF AMERICA, INC.
Labeler DUNS
083211284
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-02-28
Public Version
1
Public Version Date
2018-04-02
Public Version Status
New
Public Device Record Key
77c90594-ab72-4b52-b1cd-685d1112957c

Device Description

FILTER OVERFLOW PROTEC/BACT/W CONNEC 670

Device Characteristics

Single Use
No
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
No
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
BTA Pump, Portable, Aspiration (Manual Or Powered)

GMDN Terms

Code Name
10217 Surgical suction system

Identifiers

Type ID
Primary 04961333240753