NPseal

GUDID 00860004811343

5 Negative Pressure Wound Therapy Dressing

Guard Medical Inc.

Negative-pressure wound therapy system foam dressing, non-antimicrobial
Primary Device ID00860004811343
NIH Device Record Key8f693d59-36f8-47e2-8668-432d69d4e24c
Commercial Distribution StatusIn Commercial Distribution
Brand NameNPseal
Version Model NumberGM01-001
Company DUNS118095992
Company NameGuard Medical Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Phone8884173644
Emailinfo@guard-medical.com
Phone8884173644
Emailinfo@guard-medical.com
Phone8884173644
Emailinfo@guard-medical.com
Phone8884173644
Emailinfo@guard-medical.com
Phone8884173644
Emailinfo@guard-medical.com
Phone8884173644
Emailinfo@guard-medical.com
Phone8884173644
Emailinfo@guard-medical.com
Phone8884173644
Emailinfo@guard-medical.com
Phone8884173644
Emailinfo@guard-medical.com
Phone8884173644
Emailinfo@guard-medical.com
Phone8884173644
Emailinfo@guard-medical.com
Phone8884173644
Emailinfo@guard-medical.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture during storage
Handling Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture during storage
Handling Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture during storage
Handling Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture during storage
Handling Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture during storage
Handling Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture during storage
Handling Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture during storage
Handling Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture during storage
Handling Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture during storage
Handling Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture during storage
Handling Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture during storage
Handling Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from moisture during storage

Device Identifiers

Device Issuing AgencyDevice ID
GS100860004811343 [Primary]
GS110860004811340 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Product Code

OKONegative Pressure Wound Therapy Non-Powered Suction Apparatus

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-08-29
Device Publish Date2021-06-07

On-Brand Devices [NPseal ]

0086000481136715 Negative Pressure Wound Therapy Dressing
0086000481135010 Negative Pressure Wound Therapy Dressing
008600048113435 Negative Pressure Wound Therapy Dressing

Trademark Results [NPseal]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NPSEAL
NPSEAL
88000721 not registered Live/Pending
Guard Medical SAS
2018-06-14

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