FDA UDI In Commercial Distribution 🇺🇸 United States

Kryo

DI: B199GDMR75600 · Model: MR7-560 · PLANER LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Kryo
Primary DI
B199GDMR75600
Version / Model
MR7-560
Catalog Number
GDMR7-560
Company Name
PLANER LIMITED
Labeler DUNS
217190495
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-04-30
Public Version
1
Public Version Date
2023-05-08
Public Version Status
New
Public Device Record Key
2ce04953-af38-4dda-98ac-8623cde905a4

Device Description

MR7 Controller for use with legacy Kryo560 freezers wishing to upgrade from MRV to MR7

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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KSP Apparatus, Cell-Freezing And Reagents

GMDN Terms

Code Name
35829 Freezer control unit, programmable

Identifiers

Type ID
Primary B199GDMR75600