FDA.reportPublic FDA data

THE EMERGENCY BANDAGE

Primary DI
00850026832082
Brand
THE EMERGENCY BANDAGE
Company
EINSTEIN WORKS, LLC
Model
1
Device description
WOUNDSTOP CARE 1+
Published
2021-02-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAXTourniquet, Nonpneumatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850026832082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850026832082008500268320828500268320820850026832082

GMDN Terms#

Term, Definition table
TermDefinition
First aid gauze/bandageA wound cover intended to be used as an initial, short-term treatment after injury. It typically consists of a gauze pad (e.g., cotton wool or lint) that is attached to a roll bandage (e.g., cotton or cotton/viscose). The pad is applied directly to the wound, and the bandage is subsequently wrapped around the pad and secured. The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding, and introduce medications placed on the pad. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
098121274
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850026832105NIO NEXT GENERATION IO12021-03-03
00850026832112GO IO1GO IO-F2021-06-24
00850026832044THE EMERGENCY BANDAGE1FCP-092021-02-26
00850026832051THE EMERGENCY BANDAGE1FCP-10T2021-02-26
00850026832068THE EMERGENCY BANDAGE12021-02-26
00850026832075THE EMERGENCY BANDAGE12021-02-26
00860017001281The Emergency BandageBFCP-012020-11-02
00860017001229The Emergency Bandage1FCP-012020-10-02
00860017001236The Emergency Bandage1FCP-022020-10-02
00860017001243The Emergency Bandage1FCP-032020-10-02
00860017001250The Emergency Bandage1FCP-062020-10-02
00860017001267The Emergency Bandage1FCP-T32020-10-02
00860017001274The Emergency Bandage1FCP-09T2020-10-02
00860017001205GO IO12020-09-01
00860017001298THE EMERGENCY ELASTIC WRAP12021-08-16
10850026832119GO IO1GO IO-F2021-06-24
10850026832102NIO NEXT GENERATION IO12021-03-03
00850026832020NIO NEXT GENERATION IO1NIO-I2021-02-26
10850026832027NIO NEXT GENERATION IO1NIO-I2021-02-26
00850026832006NIO Next Generation IO1NIO-P2021-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20888277717388MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
40080196774662MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
40080196781462MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
20665973032393DukalDukal LLCGAX2025-04-08
20665973032409DukalDukal LLCGAX2025-04-08
20197344105363MEDLINEMEDLINE INDUSTRIES, INC.GAX2025-03-24
30197344006230MEDLINEMEDLINE INDUSTRIES, INC.GAX2025-03-24
00087453143478HysynalHYGENIC CORPORATION, THEGAX2025-03-10
30382903671992BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-20
30382903672050BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-20
30382903671985BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
30382903672098BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
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