AccessGUDID - DEVICE: MRV Controller Adaptor (B199GDMRVADAPTOR0)

GUDID

Device Identifier (DI) Information

Brand Name: MRV Controller Adaptor
Version or Model: GDMRV-ADAPTOR
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PLANER LIMITED

Primary DI Number: B199GDMRVADAPTOR0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 217190495 *Terms of Use

Device Description: Adaptor for MRV Contoller.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35829	Freezer control unit, programmable	A mains electricity (AC-powered) unit used together with a specific freezer where it is important that a certain predetermined freezing pattern is followed in order to preserve the contents of the freezer. This pattern may differ according to various considerations, e.g., lowering of temperature by steps over a given time. A pre-set program will be imposed upon the freezer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSP	Apparatus, Cell-Freezing And Reagents

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 5 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 78003e78-895f-4f30-8b54-ca39e783acae
Public Version Date: October 28, 2019
Public Version Number: 3
DI Record Publish Date: September 23, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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