FDA.reportPublic FDA data

NPseal Medium

Primary DI
00860004811329
Brand
NPseal Medium
Company
Guard Medical Inc.
Model
GM01-002
Device description
NPseal Medium, Advanced Negative Pressure Dressing (box of 10, Medium)
Published
2022-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OKONegative Pressure Wound Therapy Non-Powered Suction Apparatus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKONegative Pressure Wound Therapy Non-Powered Suction ApparatusGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212971000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212971000NPsealGuard Medical, Inc.2022-02-10OKO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860004811326PrimaryGS10
00860004811329Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000481132610860004811326
00860004811329008600048113298600048113290860004811329

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system foam dressing, non-antimicrobialA pad made of open-cell foam material designed to be placed into a wound during a vacuum-assisted wound closure procedure, commonly known as negative pressure wound therapy (NPWT); it does not include an antimicrobial agent(s). It is typically used to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. Under NPWT, the open-cell foam dressing decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure. It may be cut to conform to the wound. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius23 Degrees Celsius
Special Storage Condition, Specify00Keep away from moisture during storage
Special Storage Condition, Specify00Keep out of direct sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8884173644info@guard-medical.com

Regulatory Flags#

DUNS number
118095992
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860004811336NPseal LargeGM01-0032022-08-31
00860004811305NPseal (5)GM01-0012021-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998028809Solventum US LLCKCI USA, INC.OKO2025-07-23
00197998028816Solventum US LLCKCI USA, INC.OKO2025-07-23
00197998028823Solventum US LLCKCI USA, INC.OKO2025-07-23
00197998028830Solventum US LLCKCI USA, INC.OKO2025-07-23
00197998028847Solventum US LLCKCI USA, INC.OKO2025-07-23
00197998028854Solventum US LLCKCI USA, INC.OKO2025-07-23
00197998028861Solventum US LLCKCI USA, INC.OKO2025-07-23
00197998028878Solventum US LLCKCI USA, INC.OKO2025-07-23
00197998028885Solventum US LLCKCI USA, INC.OKO2025-07-23
00197998028892Solventum US LLCKCI USA, INC.OKO2025-07-23
00197998028908Solventum US LLCKCI USA, INC.OKO2025-07-23
00197998028915Solventum US LLCKCI USA, INC.OKO2025-07-23
00860004811381NPSealSTRYKER CORPORATIONOKO2024-10-22
00860004811398NPSealSTRYKER CORPORATIONOKO2024-10-22
008495540086323M™ Snap™KCI USA, INC.OKO2024-09-25
008495540086183M™ Snap™KCI USA, INC.OKO2024-08-09
008495540086563M™ Snap™KCI USA, INC.OKO2024-08-09
008495540086703M™ Snap™KCI USA, INC.OKO2024-08-09
008495540086943M™ Snap™KCI USA, INC.OKO2024-08-09
008495540087173M™ Snap™KCI USA, INC.OKO2024-08-09
00860004811350NPSealSTRYKER CORPORATIONOKO2022-08-31
00860004811367NPSealSTRYKER CORPORATIONOKO2022-08-31
00860004811336NPseal LargeGuard Medical Inc.OKO2022-08-31
00860004811343NPSealSTRYKER CORPORATIONOKO2021-06-07
00860004811305NPseal (5)Guard Medical Inc.OKO2021-06-07
04719745008177AnsCare SIMOBENQ MATERIALS CORP.OKO2021-02-09
04719745008184AnsCare SIMOBENQ MATERIALS CORP.OKO2021-02-09
04719745008191AnsCare SIMOBENQ MATERIALS CORP.OKO2021-02-09
04719745008207AnsCare SIMOBENQ MATERIALS CORP.OKO2021-02-09
04719745008214AnsCare SIMOBENQ MATERIALS CORP.OKO2021-02-09