FDA.reportPublic FDA data

EVERLIT

Primary DI
00850061187208
Brand
EVERLIT
Company
Everlit Global Inc.
Model
IB-5
Device description
6-Inch Emergency Compression Bandage - 5 Pack
Published
2026-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
00850061187208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850061187208008500611872088500611872080850061187208

GMDN Terms#

Term, Definition table
TermDefinition
First aid absorbent pad/bandageA wound cover intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) 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.

Regulatory Flags#

DUNS number
122311450
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00810173051019EVERLITRUTK-BLK2026-09-30
00810173051460EVERLIT CARE202SFAK-502026-09-30
00810173051699EVERLIT CARE203SFAK-1002026-09-30
00850061187185EVERLITIB-22026-09-28
00850061187192EVERLITIB-32026-09-28
00850061187215EVERLITIB-102026-09-28
00810173050401EVERLIT CARECARE_POFAK482026-09-22
00810173050418EVERLIT CARECARE_POFAK242026-09-22
00810173050425EVERLIT CARECARE_POFAK122026-09-22
00810173051316EVERLIT CARECFAK-252026-09-22
00810173051323EVERLIT CARECARE_FATP_122026-09-22
00810173051644EVERLIT CARECARE_KFATP_102026-09-22
00810173051163EVERLIT CAREMEDIFAK-REFILL-KIT2026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850061187185EVERLITEverlit Global Inc.GAX2026-09-28
00850061187192EVERLITEverlit Global Inc.GAX2026-09-28
00850061187215EVERLITEverlit Global Inc.GAX2026-09-28
00199536932005BluelineTransparent Supply Solutions Ltd.GAX2026-08-14
00199536932012BluelineTransparent Supply Solutions Ltd.GAX2026-08-14
00199536932029BluelineTransparent Supply Solutions Ltd.GAX2026-08-14
00199536932036BluelineTransparent Supply Solutions Ltd.GAX2026-08-14
00199536932043BluelineTransparent Supply Solutions Ltd.GAX2026-08-14
00199536932050BluelineTransparent Supply Solutions Ltd.GAX2026-08-14
00199536932067BluelineTransparent Supply Solutions Ltd.GAX2026-08-14
40884389110493MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-07-03
40888277362261MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-06-09
20888277414249MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-20
20888277717388MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
40080196774662MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
40080196781462MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
00842942010897PRIMEDpriMED Medical Products IncGAX2026-03-03
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
05060483571867TMT (Tactical Mechanical Tourniquet)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDGAX2024-10-02
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
00630094049182Bioseal Inc.BIOSEALGAX2024-01-25
00630094049199Bioseal Inc.BIOSEALGAX2024-01-25
00630094049205Bioseal Inc.BIOSEALGAX2024-01-25