FDA.reportPublic FDA data

BLDG Active

Primary DI
00818582012805
Brand
BLDG Active
Company
Innovacyn, Inc.
Model
1408
Published
2022-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818582012802PackageGS16Not in Commercial Distribution
00818582012805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081858201280210818582012802
00818582012805008185820128058185820128050818582012805

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0

Contacts#

Phone, Email table
PhoneEmail
866-787-2296customerservice@innovacyn.com

Regulatory Flags#

DUNS number
025217003
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
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
00818582010931BLDG Active14072022-10-24
00818582012423BLDG Active14032022-10-20
00818582013796Puracyn® Plus Professional Formula65502026-07-31
00818582013802Puracyn® Plus Professional Formula65512026-07-31
00818582012867Puracyn® Plus OTC60072026-07-17
00818582012881Puracyn® Plus OTC60432026-07-17
00852009002451Puracyn® Plus OTC60022026-07-17
00852009002475Puracyn® Plus OTC60012026-07-17
00852009002536Puracyn® Plus OTC60042026-07-17
00818582010764Puracyn® Plus Professional Formula 65042022-10-18
00818582010771Puracyn® Plus Professional Formula 65162022-10-19
00818582010788Puracyn® Plus Professional Formula 65082022-10-18
00818582010856Puracyn® Plus Professional Formula 65022022-10-17
00818582010993Puracyn® Plus Professional Formula 65032022-10-18
00818582011006Puracyn® Plus Professional Formula 65052022-10-18
00818582011013Puracyn® Plus Professional Formula 65092022-10-18
00818582011020Puracyn® Plus Professional Formula 65172022-10-19
00818582011310Puracyn® Plus Professional Formula 65242022-10-19
00818582011327Puracyn® Plus Professional Formula 65252022-10-19
00818582011334Puracyn® Plus Professional Formula 65272022-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06977727072488SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
10192253072723CurityCardinal Health 200, LLCFRO2026-10-08
10192253072730CurityCardinal Health 200, LLCFRO2026-10-08
10192253072747CurityCardinal Health 200, LLCFRO2026-10-08
10192253072754CurityCardinal Health 200, LLCFRO2026-10-08
10192253072761CurityCardinal Health 200, LLCFRO2026-10-08
10192253072778CurityCardinal Health 200, LLCFRO2026-10-08
10192253072785CurityCardinal Health 200, LLCFRO2026-10-08
10192253072792CurityCardinal Health 200, LLCFRO2026-10-08
10192253072808CurityCardinal Health 200, LLCFRO2026-10-08
10192253072815CurityCardinal Health 200, LLCFRO2026-10-08
10192253072822CurityCardinal Health 200, LLCFRO2026-10-08
00860014518331PurForm AMKAIROS BIOSCIENCES LLCFRO2026-10-07
00860014518348PurForm AMKAIROS BIOSCIENCES LLCFRO2026-10-07