REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM MED 431108

GUDID D7664311082

GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM MED*200

Smarthealth, Inc.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device IDD7664311082
NIH Device Record Key167852b3-ca2e-45fe-81de-348b8abd6444
Commercial Distribution StatusIn Commercial Distribution
Brand NameREFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM MED
Version Model Number431108
Catalog Number431108
Company DUNS061081477
Company NameSmarthealth, Inc.
Device Count200
DM Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com
Phone1-800-522-0800
Emailinfo@smartpractice.com

Device Dimensions

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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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Device Size Text, specify0
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Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD7664311080 [Unit of Use]
HIBCCD7664311081 [Primary]
HIBCCD7664311082 [Package]
Contains: D7664311081
Package: [12 Units]
In Commercial Distribution

FDA Product Code

LZAPolymer Patient Examination Glove

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-15
Device Publish Date2023-08-07

Devices Manufactured by Smarthealth, Inc.

D7664311062 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM XS2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM XS*200
D7664311072 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM SM2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM SM*200
D7664311082 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM MED2023-08-15GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM MED*200
D7664311082 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM MED2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM MED*200
D7664311092 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM LG2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM LG*200
D7664311102 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM XL2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM XL*200
D766408712 - QUALITOUCH LATEX PF EXAM NATURAL CF XS*2023-07-26 GLV QUALITOUCH LATEX PF EXAM NATURAL CF XS*100
D766408722 - QUALITOUCH LATEX PF EXAM NATURAL CF SM2023-07-26 GLV QUALITOUCH LATEX PF EXAM NATURAL CF SM*100
D766408732 - QUALITOUCH LATEX PF EXAM NATURAL CF MD2023-07-26 GLV QUALITOUCH LATEX PF EXAM NATURAL CF MED*100
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