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BleedArrest ER

FDA UDI

Class U (US FDA UDI)

by Hemostasis, LLC

Identity

Trade Name
BleedArrest ER FDA UDI
Generic Name
Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial FDA UDI
Device Name
BleedArrest ER Topical Hemostat Sponge FDA UDI
Model / Reference
9110264 FDA UDI
Description
BleedArrest ER Topical Hemostat Sponge FDA UDI

Identifiers

Primary DI / UDI-DI
00858439001460 FDA UDI
510(k) Number
K102459 FDA UDI
FDA Product Code
FRO FDA UDI
GMDN Term
Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial FDA UDI

Classification

Device Class
U FDA UDI
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
Width — 1.3 Centimeter FDA UDI
Length — 3.8 Centimeter FDA UDI

Category: Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial

BleedArrest ER by Hemostasis, LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial.

Cleared under the same submission

K102459 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hemostasis, LLC

Sources (1)

  • FDA UDI a3fa4ee4-af8a-49f7-9087-12326504d172 37 fields · synced Jun 1, 2026