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.
00682607611140
GS1

1
781100966 *Terms of Use
Hb meter, 100 Test Cartridges, 120 Capillary Transfer Tubes, 2 Optical Verifiers
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
No
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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GKR SYSTEM, HEMOGLOBIN, AUTOMATED
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
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
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

11c1e01a-8737-4a35-b267-6877bc1874ad
June 20, 2025
5
September 24, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
Yes
00682607000180
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)838-9502 1
support@aconlabs.com
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