AccessGUDID - DEVICE: RAPIDLab® 1200 Series 1265 (00630414515571)

GUDID

Device Identifier (DI) Information

Brand Name: RAPIDLab® 1200 Series 1265
Version or Model: 10321852
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5063769
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414515571
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: RAPIDLab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human blood. The 1265 can determine pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, FO2Hb, FCOHb, FMetHb, FHHb parameters

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?
56672	Blood gas/haemoximetry analyser IVD, point-of-care	A mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care, and often in the laboratory, for the quantitative in vitro measurement of blood pH, partial pressure of oxygen (pO2) and/or partial pressure of carbon dioxide (pCO2), and the measurement or calculation of other blood gas and co-oximetry parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient, oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb) or reduced haemoglobin (RHb), carboxy-haemoglobin (COHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb), and total haemoglobin (totHb)] in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
JGS	ELECTRODE, ION SPECIFIC, SODIUM
GKR	SYSTEM, HEMOGLOBIN, AUTOMATED
CGA	GLUCOSE OXIDASE, GLUCOSE
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
KHP	ACID, LACTIC, ENZYMATIC METHOD
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031560	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
Special Storage Condition, Specify: Max 95% RH at 25'c
Handling Environment Temperature: between -25 and 45 Degrees Celsius
Storage Environment Temperature: between 4 and 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bea8ad42-01d9-43e1-976d-1a59f91604c6
Public Version Date: November 19, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016