AccessGUDID - DEVICE: SPIFE 4000, Windows 7 (110V) (M52516200030)

GUDID

Device Identifier (DI) Information

Brand Name: SPIFE 4000, Windows 7 (110V)
Version or Model: 1620003
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HELENA LABORATORIES CORPORATION

Primary DI Number: M52516200030
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 836287433 *Terms of Use

Device Description: No description.

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):	Yes
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?
57837	Electrophoresis analyser IVD	An electrically-powered automated or semi-automated laboratory instrument or system intended to be used for the qualitative and/or quantitative in vitro determination of various molecules (e.g., DNA, RNA, proteins) in a clinical specimen based on their size, ionic charge and/or rate of migration through an electrically charged field.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CEF	ELECTROPHORETIC, PROTEIN FRACTIONATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K972274	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 71c87995-cc43-41bd-a193-c072d59ab606
Public Version Date: September 16, 2022
Public Version Number: 5
DI Record Publish Date: March 17, 2017