DEVICE: STAT PROFILE (00385480491846)

Device Identifier (DI) Information

STAT PROFILE
phox ultra/ccx
In Commercial Distribution
49184
NOVA BIOMEDICAL CORPORATION
00385480491846
GS1

20
070617139 *Terms of Use
Stat Profile pHOx Ultra/CCX Control Chemistry L4, 5 (amps)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
K110648 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Do not freeze
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Handling Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

ad726488-09d9-41dd-82a1-e404ab5efc5c
July 06, 2018
3
September 16, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 00385489491847 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(800)545-6682
info@novabio.com
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