FDA.reportPublic FDA data

AQUACEL

Primary DI
00768455118212
Brand
AQUACEL
Company
CONVATEC, PURCHASING DEPARTMENT
Model
420127
Catalog number
420127
Device description
Aquacel® Hydrofiber® Wound Dressing (Rope) With Strengthening Fiber - .39" X 18 "
Published
2022-09-05
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00768455118212PackageGS15In Commercial Distribution
10768455118219PackageGS120In Commercial Distribution
00768455148769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00768455118212007684551182127684551182120768455118212
1076845511821910768455118219
00768455148769007684551487697684551487690768455148769

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length39Inch
Length45Centimeter
Width1Centimeter
Width18Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-422-8811cic@convatec.com
+18004228811cic@convatec.com

Regulatory Flags#

DUNS number
809784593
Device count
1
DM exempt
false
Premarket exempt
true
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
10768455203946ESTEEM4236452024-09-13
10768455209481ESENTA4238272024-08-26
10768455209511ESENTA4238262024-08-26
00768455204793GENTLECATH5106002024-04-05
00768455204823GENTLECATH5106012024-04-05
00768455204854GENTLECATH5106022024-04-05
00768455207145GENTLECATH5106032024-04-05
00768455207169GENTLECATH5106042024-04-05
00768455207206GENTLECATH5106052024-04-05
10815947021172CURE PRODUCTSHM16UK2024-03-30
10768455203922ESTEEM4236432024-03-20
10768455203939ESTEEM4236442024-03-20
10768455203953ESTEEM4236462024-03-20
10768455203960ESTEEM4236472024-03-20
10768455203977ESTEEM4236482024-03-20
10768455204004ESTEEM4236512024-03-20
10768455204011ESTEEM4236522024-03-20
10768455204028ESTEEM4236532024-03-20
10768455204035ESTEEM4236542024-03-20
10768455204059ESTEEM4236562024-03-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07333350377205Mepore®Mölnlycke Health Care ABNAC2026-05-23
07333350625993Mepore®Mölnlycke Health Care ABNAC2026-05-23
00361554003412Silicone Superabsorbent Bordered DressingGentell, LLCNAC2026-05-19
00361554003436Silicone Superabsorbent Bordered DressingGentell, LLCNAC2026-05-19
00361554003450Silicone Superabsorbent Bordered DressingGentell, LLCNAC2026-05-19
20197344025340MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-03-13
30197344016840MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-03-06
30197344016857MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-03-06
07333350045845Mepilex® TransferMölnlycke Health Care ABNAC2026-02-26
07333350416249Mepilex® TransferMölnlycke Health Care ABNAC2026-02-26
20665973033024DukalDukal LLCNAC2026-02-26
00197998275326Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998275951Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998275999Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998276033Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998276071Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998276118Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998276156Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998276194Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998276231Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998276279Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998276316Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00810178883646ViveCareVIVE HEALTH LLCNAC2026-02-05
00810178883653ViveCareVIVE HEALTH LLCNAC2026-02-05
00810178883660ViveCareVIVE HEALTH LLCNAC2026-02-05
00810178883677ViveCareVIVE HEALTH LLCNAC2026-02-05
20197344016812MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-02-05
20197344016836MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-02-05
00198926007453OrchidQuest USA Corp.NAC2026-02-03
00198926007460OrchidQuest USA Corp.NAC2026-02-03