Primary Device ID | 04015630913121 |
NIH Device Record Key | 6b4d61b3-472d-4366-8400-a90aa18664c6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Elecsys PTH CalSet |
Version Model Number | 11972219122 |
Catalog Number | 11972219122 |
Company DUNS | 315028860 |
Company Name | Roche Diagnostics GmbH |
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 | true |
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 |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04015630913121 [Primary] |
JIT | CALIBRATOR, SECONDARY |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-12-23 |
Device Publish Date | 2016-09-20 |
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07613336227770 - Potassium electrode | 2025-03-13 |
07613336227787 - Chloride electrode | 2025-03-13 |
07613336227794 - Reference electrode | 2025-03-13 |
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