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Hydrofera Blue READY - Border

FDA 510(k)FDA UDI

U (US FDA 510(k))

510(k) K190268

by Hydrofera, Llc.

Identity

Trade Name
Hydrofera Blue Ready - Border FDA UDI
Generic Name
Wound-nonadherent dressing, permeable, antimicrobial FDA UDI
Device Name
Hydrofera Blue Ready - Border 7.9" x 7.5" Antibacterial Foam Dressing FDA UDI
Model / Reference
HBRB7975 FDA UDI
Description
Hydrofera Blue Ready - Border 7.9" x 7.5" Antibacterial Foam Dressing FDA UDI

Identifiers

Primary DI / UDI-DI
10854827008421 FDA UDI
510(k) Number
K190268 FDA 510(k)FDA UDI
FDA Product Code
FRO FDA 510(k)FDA UDI
GMDN Term
Wound-nonadherent dressing, permeable, antimicrobial FDA UDI

Classification

Device Class
U FDA 510(k)FDA UDI
Advisory Committee
Unknown FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 7.5 Inch FDA UDI
Width — 7.9 Inch FDA UDI

Hydrofera Blue READY - Border by Hydrofera, Llc. — U — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hydrofera, Llc.
FDA Applicant
Hydrofera, LLC

Sources (2)

  • FDA 510(k) K190268 24 fields · synced Jun 19, 2026
  • FDA UDI 04de790f-604d-465c-92ec-f8d4e698006d 35 fields · synced May 26, 2026