FDA.reportPublic FDA data

Curity

Primary DI
30884521138135
Brand
Curity
Company
Cardinal Health, Inc.
Model
8044AMD
Catalog number
8044AMD
Device description
AMD Antimicrobial Non-woven Sponges,4 Ply, 0.2% Polyhexamethylene Biguanide HCI (PHMB)
Published
2018-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EFQGAUZE/SPONGE, INTERNAL
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFQGauze/Sponge, InternalUnknownU
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521138138PackageGS150In Commercial Distribution
30884521138135PackageGS11200In Commercial Distribution
10884521138131PrimaryGS10
40884521138132Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452113813820884521138138
3088452113813530884521138135
1088452113813110884521138131
4088452113813240884521138132

GMDN Terms#

Term, Definition table
TermDefinition
Germicidal spongeA device impregnated with an antimicrobial agent and intended to be applied to a surgical incision, other skin wound, or an internal structure to control bleeding, absorb fluid, and to protect against contamination. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Inch
Width4Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080935429
Device count
2
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
10884521189652Monoject1186000444T1186000444T2016-09-24
10884527007110Argyle888816305588881630552016-09-24
20885380173537Curity7267G7267G2019-11-14
20885380173568Curity9024G9024G2019-11-14
20885380174473Curity1806G1806G2019-11-14
20885380174480Curity1903G1903G2019-11-14
20885380174558Curity3968G3968G2019-11-14
20885380174589Dermacea441407G441407G2019-11-14
20885380174596Dermacea441408G441408G2019-11-14
20885380174602Curity6241G6241G2019-11-14
20885380174619Curity6242PG6242PG2019-11-14
20885380174626Curity6318G6318G2019-11-14
20885380174633Curity6939G6939G2019-11-14
20885380174657Curity8043G8043G2019-11-14
20885380174664Curity8044G8044G2019-11-14
20885380174688Curity8046G8046G2019-11-14
20885380174886Curity7605G7605G2019-11-14
00885380173830Curity6241G6241G2020-10-23
00885380173847Curity6242PG6242PG2020-10-23
00885380173878Curity8042G8042G2020-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00852421007850Pure&CleanPure & Clean, LLCFRO2026-07-29
04260056880667XPERIENCE Advanced Surgical IrrigationOSARTIS GmbHFRO2026-07-28
10841495149815QUIKCLOTTELEFLEX INCORPORATEDFRO2026-07-27
B665AC510011AC5 Advanced Wound SystemArch Therapeutics, Inc.FRO2026-07-24
B665AVX030011VIA LinxArch Therapeutics, Inc.FRO2026-07-24
00852421007300Pure&CleanPure & Clean, LLCFRO2026-07-22
00818582012867Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00818582012881Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002451Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002475Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002536Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
09551012610479ELECTROCYN somaV3BIO SDN. BHD.FRO2026-07-16
10197344176007MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176014MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176021MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176038MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
04260056880650BLASTXOSARTIS GmbHFRO2026-07-12
00850088144604CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144611CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144628CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10