FDA.reportPublic FDA data

BE SMART GET PREPARED

Primary DI
00020424080013
Brand
BE SMART GET PREPARED
Company
TOTAL RESOURCES INTERNATIONAL INC.
Model
00-GAU-8001YOU
Catalog number
00-GAU-8001YOU
Device description
Be Smart Get Prepared® Blood Stopping (Hemostatic Gauze) 4” x 4” 1/ply/ 1 pc
Published
2024-12-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
00020424080013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00020424080013000204240800130204240800130020424080013

GMDN Terms#

Term, Definition table
TermDefinition
Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobialA non-bioabsorbable device derived from plant polysaccharides [e.g., micro-dispersed oxidized cellulose (M-Doc), oxidized regenerated cellulose (ORC), calcium alginate] intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound, to facilitate local haemostasis; it does not contain an antimicrobial agent. It is available in various forms (e.g., gel, spray, powder, ointment, plaster/gauze pad, fibre/wool) that can be applied directly to the wound where it forms a seal until removed. The device is intended for use in the home or healthcare facility. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
790160535
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00020424221249BE SMART GET PREPARED22EME06124CC; 22EME06124CCPLTQTR2026-04-21
20020424226811BE SMART GET PREPARED22EME06081NEWPLT2026-04-02
00020424010157BE SMART GET PREPARED20HBC01015REV5X004BQ2VVL2026-03-31
00020424016432ESSENTIALS16LOW0164312504542026-03-27
00020424100087Be Smart Get Prepared10COM15008REV12025-11-24
00020424060770BE SMART GET PREPARED22EME06077; 22EME06077A2025-11-21
00020424201159BE SMART GET PREPARED20HBC01015CCREV3; 20HBC01015CCREV4; 20HBC01015REV4X0013DSLAP2024-01-09
00020424220815BE SMART GET PREPARED22EME06081NEWCC2025-03-05
00781002848950L.H. Dottie16DOT01405CS2025-02-25
00020424210083BE SMART GET PREPARED03HBC21073PK82025-01-24
00020424101824BE SMART GET PREPARED10HBC01082REV1A2025-01-10
00020424150075BE SMART GET PREPARED10COM15007REV22025-01-10
00020424014025Be Smart Get Prepared10HBC014022025-01-09
00020424211745Be Smart Get Prepared03HBC211742025-01-09
00020424211851Be Smart Get Prepared03HBC211852025-01-09
00020424060879BE SMART GET PREPARED22EME06087REV1; 22EME06087REV22024-01-05
00020424013639BE SMART GET PREPARED10COM01363; 10HBC01363; 10HBC01363RECOMX0044NVFNL2024-01-12
00020424021429BE SMART GET PREPARED10OUT02142; 10OUT02142REV12024-01-05
00020424199975Be Smart Get Prepared19-NAS-04997CS2024-12-10
00020424226145Be Smart Get Prepared22EME060142024-11-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26
00850087488723CeeportCEEPORT INC.FRO2026-08-26
00850087488730CeeportCEEPORT INC.FRO2026-08-26
00850087488846CeeportCEEPORT INC.FRO2026-08-26
00850087488853CeeportCEEPORT INC.FRO2026-08-26
00850087488747CeeportCEEPORT INC.FRO2026-08-25
04260056880636BactisureOSARTIS GmbHFRO2026-08-25
05000223503284ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
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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