PINK RIBBON LATEX PF EXAM PNK SM 43223

GUDID D766432232

GLV PINK RIBBON LATEX PF EXAM PNK SM*100

Smarthealth, Inc.

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Primary Device IDD766432232
NIH Device Record Keyf40211b4-af55-4c86-a908-7a9ebc28d72e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePINK RIBBON LATEX PF EXAM PNK SM
Version Model Number43223
Catalog Number43223
Company DUNS061081477
Company NameSmarthealth, Inc.
Device Count100
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 Latextrue
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

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD766432230 [Unit of Use]
HIBCCD766432231 [Primary]
HIBCCD766432232 [Package]
Contains: D766432231
Package: case [10 Units]
In Commercial Distribution

FDA Product Code

LYYLatex 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 Date2023-07-25
Device Publish Date2023-07-17

Devices Manufactured by Smarthealth, Inc.

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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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