FDA UDI In Commercial Distribution 🇺🇸 United States

Thora-Seal

DI: 10884521101128 · Model: 8884713900 · Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Thora-Seal
Primary DI
10884521101128
Version / Model
8884713900
Catalog Number
8884713900
Company Name
Cardinal Health, Inc.
Labeler DUNS
080935429
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-24
Public Version
7
Public Version Date
2023-06-02
Public Version Status
Update
Public Device Record Key
c3540d6c-2d87-4546-80f0-3ca75faa3cc8

Device Description

Replacement Collection Chamber,Three Chamber 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
KDQ BOTTLE, COLLECTION, VACUUM

GMDN Terms

Code Name
36966 Autotransfusion system blood collection container

Identifiers

Type ID
Package 20884521101125
Primary 10884521101128

Customer Contacts

Device Sizes

Type Value Unit Text
Total Volume 2500 Milliliter

Storage Conditions

Type
Special Storage Condition, Specify
Special Conditions
Keep dry;AVOID DIRECT SUNLIGHT