FDA UDI Not in Commercial Distribution 🇺🇸 United States

BD Trucount

DI: 00382903403356 · Model: 340335 · BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
BD Trucount
Primary DI
00382903403356
Version / Model
340335
Catalog Number
340335
Company Name
BECTON, DICKINSON AND COMPANY
Labeler DUNS
024230633
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-06-08
Public Version
9
Public Version Date
2023-09-21
Public Version Status
Update
Public Device Record Key
7bb782ea-c141-45c7-9f3a-1efa5abc797f
Distribution End Date
2023-09-20

Device Description

BD Trucount™ Controls

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
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
No
Sterilization Prior Use
No

Product Codes

Code Name
JPK Mixture, hematology quality control

GMDN Terms

Code Name
58048 Optical laboratory instrument performance standard calibrator/control IVD, single-use

Identifiers

Type ID
Primary 00382903403356

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius