FDA.reportPublic FDA data

Ceeport

Primary DI
00850087488730
Brand
Ceeport
Company
CEEPORT INC.
Model
61344B
Device description
Medical Xeroform Petrolatum Dressing 4"x4"
Published
2026-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K181478000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181478000Roosin Xeroform Petrolatum DressingRoosin Medical Co., Ltd.2019-09-13FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850087488570PackageGS125In Commercial Distribution
00850087488754PackageGS110In Commercial Distribution
00850087488730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850087488570008500874885708500874885700850087488570
00850087488754008500874887548500874887540850087488754
00850087488730008500874887308500874887300850087488730

GMDN Terms#

Term, Definition table
TermDefinition
Cotton burn dressing, non-antimicrobialA covering designed to treat small to large patient burns made of woven cotton impregnated with wound gel (e.g., hydrogel) and applied over the burn to protect against infection, minimize trauma and skin damage, moisten and cool the burn area, and prevent burn progression. It is available in various sizes (e.g., 1x1 m to 1x2 m), prefabricated shapes (e.g., vest) and may be body contoured; it does not include an antimicrobial agent(s). It is typically used by emergency medical services (EMS) and critical care units, but may also be used in the home. This is a single-use device.

Regulatory Flags#

DUNS number
030473690
Device count
1
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850087488877Ceeport64125A-BL64125A-BL2026-09-29
00850087488723Ceeport61318B2026-08-26
00850087488785Ceeport642110B2026-08-26
00850087488792Ceeport642210B2026-08-26
00850087488808Ceeport63134B-SK2026-08-26
00850087488815Ceeport631344B-SK2026-08-26
00850087488822Ceeport63144B-SK2026-08-26
00850087488839Ceeport631474B-SK2026-08-26
00850087488846Ceeport62122B2026-08-26
00850087488853Ceeport62144B2026-08-26
00850087488747Ceeport61359B2026-08-25
00850087488358Ceeport615447A615447A2026-05-29
00850087488273Ceeport6331716A6331716A2026-06-08
00850087488259Ceeport62033A62033A2026-05-29
00850087488266Ceeport62022A62022A2026-05-29
00850087488365Ceeport61422A61422A2026-05-29
00850087488372Ceeport61444A61444A2026-05-29
00850087488396Ceeport61222A61222A2026-05-29
00850087488433CeeportE61755AE61755A2026-05-29
00850087488440CeeportE61748AE61748A2026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818582013628Puracyn Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.FRO2026-10-16
05059884011164Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011171Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011188Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011195Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011201Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011218Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011225Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
00841277111378Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111385Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111392Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111408Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111382Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111405Novera SeamHarps USA, Inc.FRO2026-10-14
00050428034712CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428034743CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428142349CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428341728CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
10885380214813DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214820DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214837DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214844DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214851DermaceaCardinal Health 200, LLCFRO2026-10-09
06977727072259Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072266Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072273Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072280Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072457SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072464SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072471SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08