DIASTIX® 2803

GUDID 40301932803218

Reagent strips for urinalysis - glucose. 100 test strips.

ASCENSIA DIABETES CARE US INC.

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Primary Device ID40301932803218
NIH Device Record Keyc2929ac0-f4c2-4d2c-9e33-911cd9673015
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIASTIX®
Version Model Number2803
Catalog Number2803
Company DUNS080028910
Company NameASCENSIA DIABETES CARE US INC.
Device Count100
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 Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100301932803012 [Unit of Use]
GS100301932803210 [Package]
Contains: 10301932803217
Package: carton [1 Units]
In Commercial Distribution
NDC/NHRIC0193-2802-21 [Secondary]
GS110301932803217 [Primary]
GS140301932803218 [Package]
Contains: 00301932803210
Package: shipper/case [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-07
Device Publish Date2016-09-16

On-Brand Devices [DIASTIX®]

40301932806509Reagent strips for urinalysis - glucose. 50 test strips.
40301932803218Reagent strips for urinalysis - glucose. 100 test strips.

Trademark Results [DIASTIX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DIASTIX
DIASTIX
72047810 0672032 Live/Registered
AMES COMPANY, INC.
1958-03-17

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