FDA UDI In Commercial Distribution 🇺🇸 United States

ARCHV – Antigen Retrieval Chamber High Voltage (Recertified)

DI: 00847627035509 · Model: DCARC0003-R · BIOCARE MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
ARCHV – Antigen Retrieval Chamber High Voltage (Recertified)
Primary DI
00847627035509
Version / Model
DCARC0003-R
Company Name
BIOCARE MEDICAL LLC
Labeler DUNS
806617825
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-07-02
Public Version
1
Public Version Date
2024-07-10
Public Version Status
New
Public Device Record Key
61265a7c-875a-43cc-a492-2b50e978c308

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

GMDN Terms

Code Name
66288 Pressurized incubator IVD

Identifiers

Type ID
Primary 00847627035509