DEVICE: Mission Plus Hemoglobin (Hb) Monitoring System (00682607611140)
Device Identifier (DI) Information
Mission Plus Hemoglobin (Hb) Monitoring System
C112-3061
In Commercial Distribution
Acon Laboratories, Inc.
C112-3061
In Commercial Distribution
Acon Laboratories, Inc.
Hb meter, 100 Test Cartridges, 120 Capillary Transfer Tubes, 2 Optical Verifiers
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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32435 | Haemoglobin analyser IVD, point-of-care |
A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care, and often also in the laboratory, to determine the concentration of haemoglobin in a clinical specimen, using technology which may include colorimetry, electrometry or photometry.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GKR | SYSTEM, HEMOGLOBIN, AUTOMATED |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keep out of direct sunlight |
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify: Store in a cool, dry place |
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
11c1e01a-8737-4a35-b267-6877bc1874ad
June 20, 2025
5
September 24, 2016
June 20, 2025
5
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20682607611144 | 12 | 00682607611140 | In Commercial Distribution | carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)838-9502
1
support@aconlabs.com
support@aconlabs.com