Calibration Solution 943-837

GUDID 05700699438379

S1545 Calibration Solution 1 pH 7.383, 140 mL. For ABL5, BPH5

Radiometer Medical ApS

Multiple blood gas analyte IVD, calibrator

• Primary Device ID: 05700699438379
• NIH Device Record Key: 88bf35e0-3789-44c7-8842-9f3c7cec76ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calibration Solution
• Version Model Number: 943-837
• Catalog Number: 943-837
• Company DUNS: 308667539
• Company Name: Radiometer Medical ApS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700699438379 [Primary]

FDA Product Code

• CHL: ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-01

On-Brand Devices [Calibration Solution]

• 05700699440693: 1100 CALPACK Calibration Solution for ABL77
• 05700699440648: S1720 Calibration Solution 1 200 mL, for ABL7XX.
• 05700699440259: S1730 Calibration Solution 2 200 mL, for ABL7XX
• 05700699440242: S1720 Calibration Solution 1 200 mL, for ABL7XX
• 05700699440211: S7770 tHb calibration Solution (box of 4 ampoules), for ABL7XX/8XX
• 05700699438393: S1555 Calibration Solution 2 pH 6.841, 140 mL. For ABL5, BPH5
• 05700699438379: S1545 Calibration Solution 1 pH 7.383, 140 mL. For ABL5, BPH5