AccessGUDID - DEVICE: STAT PROFILE (00385480489355)

GUDID

Device Identifier (DI) Information

Brand Name: STAT PROFILE
Version or Model: phox ultra/ccx
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 48935
Company Name: NOVA BIOMEDICAL CORPORATION

Primary DI Number: 00385480489355
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 070617139 *Terms of Use

Device Description: Stat Profile pHOx Ultra/CCX Blood Gas Controls Multipack L1, 2, 3 (Amps)

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:	Yes
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?
56660	Assisted reproduction centrifuge tube	A sterile container (a dedicated sealable centrifuge tube) intended for the preparation, centrifuging and storage of biological samples used in assisted reproduction techniques (ART), e.g., sperm. It is intended for use in assisted reproduction clinics and is specific to the procedure(s) and policies used in, in vitro fertilization (IVF). Its main application being the separation of unwanted biological material of human origin, e.g., by adding semen and a gradient to the biological material in the tube and applying centrifugation, this facilitates the removal of seminal plasma, dead sperm and other cells; spermatozoa of highest mobility can be thus selected. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJY	Multi-analyte controls, all kinds (assayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110648	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
Handling Environment Temperature: between 24 and 26 Degrees Celsius
Special Storage Condition, Specify: Do not freeze
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4454f39b-7535-4f11-b1d9-2a41320d7618
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016