FDA UDI In Commercial Distribution 🇺🇸 United States

EXACTAMIX

DI: 08033718000910 · Model: E3005OD · HAEMOTRONIC SPA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

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Basic Information

Brand Name
EXACTAMIX
Primary DI
08033718000910
Version / Model
E3005OD
Catalog Number
5030050016
Company Name
HAEMOTRONIC SPA
Labeler DUNS
430857771
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-11-20
Public Version
3
Public Version Date
2024-09-19
Public Version Status
Update
Public Device Record Key
2cfe483c-5d06-405b-9790-6691b4de7ddf

Device Description

500 mL Exacatmix Empty EVA bag

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
Yes
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
KPE Container, I.V.

GMDN Terms

Code Name
35127 Intravenous administration bag/bottle

Identifiers

Type ID
Primary 08033718000910
Package 28033718000914