Primary Device ID | 00682607000197 |
NIH Device Record Key | 9f19fbf1-a661-44af-9369-b3632e0f036a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Mission Plus Hemoglobin (Hb) Test Cartridges |
Version Model Number | C132-3021 |
Company DUNS | 781100966 |
Company Name | ACON LABORATORIES, INC. |
Device Count | 10 |
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 |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00682607000197 [Primary] |
GS1 | 00682607000234 [Unit of Use] |
GKR | SYSTEM, HEMOGLOBIN, AUTOMATED |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-24 |
20682607610543 | Box of 50 Test Cartridges (5 vials of 10) and 60 Capillary Transfer Tubes (3 bags of 20) |
20682607610536 | Box of 50 Test Cartridges (5 vials) |
00682607000197 | Vial of 10 Test Cartridges |