FDA UDI In Commercial Distribution 🇺🇸 United States

DAR

DI: 10884521066908 · Model: 350/5865Z · Covidien LP
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
DAR
Primary DI
10884521066908
Version / Model
350/5865Z
Company Name
Covidien LP
Labeler DUNS
058614483
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-04-15
Public Version
3
Public Version Date
2023-05-09
Public Version Status
Update
Public Device Record Key
7746c5a1-57ad-4ead-b682-eb9edb26496c

Device Description

Electrostatic Filter Large

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
No
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
CAH Filter, bacterial, breathing-circuit

GMDN Terms

Code Name
60837 Microbial medical gas filter, single-use

Identifiers

Type ID
Package 20884521066905
Primary 10884521066908

Customer Contacts

Device Sizes

Type Value Unit Text
Device Size Text, specify Tidal Volume, 300-1500, ML;

Storage Conditions

Type
Special Storage Condition, Specify
Special Conditions
Fragile, Keep dry, This side up