FDA.reportPublic FDA data

IMed Products

Primary DI
10853155008684
Brand
IMed Products
Company
INTEGRATED MEDICAL SYSTEMS, INC.
Model
IM36026
Catalog number
IM36026
Device description
"IMedGuard 1""/4mm Disc w/CHG, 10/Bx"
Published
2025-04-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200641000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200641000HaloGUARD Protective Disc with CHGAttwill Medical Solutions2020-09-03FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20853155008681PackageGS140In Commercial Distribution
10853155008684PrimaryGS10
00853155008687Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085315500868120853155008681
1085315500868410853155008684
00853155008687008531550086878531550086870853155008687

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous catheter protector, professionalA dressing-like device intended to be used by a healthcare professional to cover and protect a percutaneous access cannula/catheter site (typically intravenous) to manage and help prevent complications (e.g., leakage, bleeding, infection). It is available in a variety of designs which may include a foam pad intended to absorb exudates/blood and a transparent shield that allows observation, sometimes with holes for ventilation. This is a single-use device.

Regulatory Flags#

DUNS number
962364444
Device count
10
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810110920160IMed ProductsIM1250IM12502025-05-06
10810110920702IMed ProductsIM1266CKIM1266CK2025-05-06
00853155008878IMed ProductsIM54085IM540852025-07-03
00853155008885IMed ProductsIM54086IM540862025-07-03
00853155008892IMed ProductsIM54087IM540872025-07-03
00853155008908IMed ProductsIM54088IM540882025-07-03
00853155008915IMed ProductsIM54089IM540892025-07-03
00853155008939IMed ProductsIM54091IM540912025-07-03
10853155008875IMed ProductsIM54085IM540852025-07-03
10853155008882IMed ProductsIM54086IM540862025-07-03
10853155008899IMed ProductsIM54087IM540872025-07-03
10853155008905IMed ProductsIM54088IM540882025-07-03
10853155008912IMed ProductsIM54089IM540892025-07-03
10853155008936IMed ProductsIM54091IM540912025-07-03
00810110920163IMed ProductsIM1250IM12502025-05-06
00810110920705IMed ProductsIM1266CKIM1266CK2025-05-06
10810110921198IMed ProductsIM68055IM680552025-04-22
10810110921204IMed ProductsIM68100IM681002025-04-22
10810110921211IMed ProductsIM68102IM681022025-04-22
10853155008370IMed ProductsIM68130IM681302025-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277415010MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
10888277415027MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
00841277111187Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111200Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111224Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26
00850087488723CeeportCEEPORT INC.FRO2026-08-26
00850087488730CeeportCEEPORT INC.FRO2026-08-26
00850087488846CeeportCEEPORT INC.FRO2026-08-26
00850087488853CeeportCEEPORT INC.FRO2026-08-26
00850087488747CeeportCEEPORT INC.FRO2026-08-25
04260056880636BactisureOSARTIS GmbHFRO2026-08-25
05000223503284ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
05000223503697ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
00197998001369Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998002861Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998173523Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998173554Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432385Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432415Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998433559Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
00050428034873CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
00050428034880CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
10197344169436MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29