FDA UDI In Commercial Distribution 🇺🇸 United States

Roche Whole Blood Collection Tube

DI: 07613336166604 · Model: 08827907001 · Roche Molecular Systems, Inc.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Roche Whole Blood Collection Tube
Primary DI
07613336166604
Version / Model
08827907001
Catalog Number
08827907001
Company Name
Roche Molecular Systems, Inc.
Labeler DUNS
071674100
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-12-19
Public Version
2
Public Version Date
2021-11-10
Public Version Status
Update
Public Device Record Key
b0bd9b65-532e-4618-97ed-4f77a026a818

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
No
Sterilization Prior Use
No

GMDN Terms

Code Name
57898 Evacuated blood collection tube IVD, nucleic acid stabilizer

Identifiers

Type ID
Primary 07613336166604