nPro 99+ Surgical Mask, Berry Compliant 6412107

GUDID 00860004362913

The nPro single use, disposable surgical masks provide excellent protection and are designed to meet the ASTM F2100-19 Level 1 requirements. The 3-ply pleated mask fabric can be vertically adjusted to cover the mouth and nose. The masks have an enclosed flexible nose wire and feature soft and strong ear-loops to ensure a snug and comfortable fit. All materials are not made with natural rubber latex.

N P Medical Inc.

Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use
Primary Device ID00860004362913
NIH Device Record Key61db568a-19b2-4dac-b3fe-8292d192ba62
Commercial Distribution StatusIn Commercial Distribution
Brand NamenPro 99+ Surgical Mask, Berry Compliant
Version Model Number6412107
Catalog Number6412107
Company DUNS118211010
Company NameN P Medical Inc.
Device Count1
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone(978)368-6854
Emailinfo@npmedical.com
Phone(978)368-6854
Emailinfo@npmedical.com
Phone(978)368-6854
Emailinfo@npmedical.com
Phone(978)368-6854
Emailinfo@npmedical.com
Phone(978)368-6854
Emailinfo@npmedical.com
Phone(978)368-6854
Emailinfo@npmedical.com
Phone(978)368-6854
Emailinfo@npmedical.com
Phone(978)368-6854
Emailinfo@npmedical.com
Phone(978)368-6854
Emailinfo@npmedical.com
Phone(978)368-6854
Emailinfo@npmedical.com
Phone(978)368-6854
Emailinfo@npmedical.com
Phone(978)368-6854
Emailinfo@npmedical.com
Phone(978)368-6854
Emailinfo@npmedical.com
Phone(978)368-6854
Emailinfo@npmedical.com
Phone(978)368-6854
Emailinfo@npmedical.com
Phone(978)368-6854
Emailinfo@npmedical.com

Device Dimensions

Length17.5 Centimeter
Width9.5 Centimeter
Length17.5 Centimeter
Width9.5 Centimeter
Length17.5 Centimeter
Width9.5 Centimeter
Length17.5 Centimeter
Width9.5 Centimeter
Length17.5 Centimeter
Width9.5 Centimeter
Length17.5 Centimeter
Width9.5 Centimeter
Length17.5 Centimeter
Width9.5 Centimeter
Length17.5 Centimeter
Width9.5 Centimeter
Length17.5 Centimeter
Width9.5 Centimeter
Length17.5 Centimeter
Width9.5 Centimeter
Length17.5 Centimeter
Width9.5 Centimeter
Length17.5 Centimeter
Width9.5 Centimeter
Length17.5 Centimeter
Width9.5 Centimeter
Length17.5 Centimeter
Width9.5 Centimeter
Length17.5 Centimeter
Width9.5 Centimeter
Length17.5 Centimeter
Width9.5 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep masks in original packaging, closed and sealed in cool locations. Keep away from fire, rain and strong direct light.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep masks in original packaging, closed and sealed in cool locations. Keep away from fire, rain and strong direct light.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep masks in original packaging, closed and sealed in cool locations. Keep away from fire, rain and strong direct light.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep masks in original packaging, closed and sealed in cool locations. Keep away from fire, rain and strong direct light.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep masks in original packaging, closed and sealed in cool locations. Keep away from fire, rain and strong direct light.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep masks in original packaging, closed and sealed in cool locations. Keep away from fire, rain and strong direct light.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep masks in original packaging, closed and sealed in cool locations. Keep away from fire, rain and strong direct light.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep masks in original packaging, closed and sealed in cool locations. Keep away from fire, rain and strong direct light.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep masks in original packaging, closed and sealed in cool locations. Keep away from fire, rain and strong direct light.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep masks in original packaging, closed and sealed in cool locations. Keep away from fire, rain and strong direct light.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep masks in original packaging, closed and sealed in cool locations. Keep away from fire, rain and strong direct light.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep masks in original packaging, closed and sealed in cool locations. Keep away from fire, rain and strong direct light.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep masks in original packaging, closed and sealed in cool locations. Keep away from fire, rain and strong direct light.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep masks in original packaging, closed and sealed in cool locations. Keep away from fire, rain and strong direct light.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep masks in original packaging, closed and sealed in cool locations. Keep away from fire, rain and strong direct light.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep masks in original packaging, closed and sealed in cool locations. Keep away from fire, rain and strong direct light.

Device Identifiers

Device Issuing AgencyDevice ID
GS100860004362913 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FXXMask, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-14
Device Publish Date2021-04-06

Devices Manufactured by N P Medical Inc.

00860004362913 - nPro 99+ Surgical Mask, Berry Compliant 2021-04-14The nPro single use, disposable surgical masks provide excellent protection and are designed to meet the ASTM F2100-19 Level 1 requirements. The 3-ply pleated mask fabric can be vertically adjusted to cover the mouth and nose. The masks have an enclosed flexible nose wire and feature soft and strong ear-loops to ensure a snug and comfortable fit. All materials are not made with natural rubber latex.
00860004362913 - nPro 99+ Surgical Mask, Berry Compliant 2021-04-14 The nPro single use, disposable surgical masks provide excellent protection and are designed to meet the ASTM F2100-19 Level 1 r
00860004362906 - nPro 99+ Surgical Mask 2021-03-05 The nPro single use, disposable surgical masks provide excellent protection and are designed to meet the ASTM F2100-19 Level 1 r
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.