AccessGUDID - DEVICE: RAPIDPoint® 400/405/500 Wash/Waste Cartridge (00630414444581)

GUDID

Device Identifier (DI) Information

Brand Name: RAPIDPoint® 400/405/500 Wash/Waste Cartridge
Version or Model: 10310310
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 118677
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414444581
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: RAPIDPoint® 400/405/500 Wash/Waste Cartridge is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 400/405/500 analyzers.

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):	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?
59058	Wash/cleaning solution IVD, automated/semi-automated system	A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CGA	GLUCOSE OXIDASE, GLUCOSE
JGS	ELECTRODE, ION SPECIFIC, SODIUM
GKF	INSTRUMENT, HEMATOCRIT, AUTOMATED
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
JFP	ELECTRODE, ION SPECIFIC, CALCIUM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002738	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
Storage Environment Temperature: between 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 982a7a75-276a-4adb-8b9e-f56f2798409e
Public Version Date: November 19, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016