Mission Capillary Transfer Tubes

GUDID 00682607000227

Bag of 25 capillary transfer tubes (25/bag)

ACON LABORATORIES, INC.

Haemoglobin analyser IVD, point-of-care
Primary Device ID00682607000227
NIH Device Record Keyf06cea26-008a-4521-8ad2-c8ed84a902b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMission Capillary Transfer Tubes
Version Model NumberC121-3081
Company DUNS781100966
Company NameACON LABORATORIES, INC.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100682607000227 [Primary]
GS100682607000258 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKRSYSTEM, HEMOGLOBIN, AUTOMATED

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [Mission Capillary Transfer Tubes]

20682607200010Box of 50 capillary transfer tubes (25/bag)
00682607000227Bag of 25 capillary transfer tubes (25/bag)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.