FDA.reportPublic FDA data

easycare

Primary DI
00850063404389
Brand
easycare
Company
Synchronis Medical, LLC
Model
1215-20000
Catalog number
1215-20000
Device description
"Flat, Disposable, 1"" x 18"" Tourniquet"
Published
2025-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
00850063404396PackageGS1250In Commercial Distribution
00850063404402PackageGS11000In Commercial Distribution
00850063404389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850063404396008500634043968500634043960850063404396
00850063404402008500634044028500634044020850063404402
00850063404389008500634043898500634043890850063404389

GMDN Terms#

Term, Definition table
TermDefinition
Tourniquet cuff, single-useA band-like device that is applied around an extremity (arm or leg) and connected to a tourniquet unit to apply a controlled pressure to restrict blood circulation and prevent normal blood flow to or from the distal area during a surgical intervention or serious injury. The tourniquet unit is used to provide the pressure within the cuff and display the pressure applied. The cuff usually comprises a dual-chamber allowing for alternation of the pressure site to avoid tissue damage or necrosis. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
877.443.9080info@synchronismedical.com

Regulatory Flags#

DUNS number
080160207
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850015884641easycare3200-100003200-100002026-02-20
00850015884757easycare3200-100023200-100022026-02-20
00850015884955easycare3200-100103200-100102026-02-20
00850015884979easycare3200-100123200-100122026-02-20
00850015884993easycare3200-100143200-100142026-02-20
00850063404013easycare3200-100163200-100162026-02-20
00850063404037easycare3200-100203200-100202026-02-20
00850015884658easycare3200-100003200-100002026-02-20
00850015884764easycare3200-100023200-100022026-02-20
00850015884962easycare3200-100103200-100102026-02-20
00850015884986easycare3200-100123200-100122026-02-20
00850063404006easycare3200-100143200-100142026-02-20
00850063404020easycare3200-100163200-100162026-02-20
00850063404044easycare3200-100203200-100202026-02-20
00860000925303easycare3200-100383200-100382026-02-20
00850063404051easycare3200-100223200-100222026-02-13
00850063404075easycare3200-100243200-100242026-02-13
00850063404099easycare3200-100263200-100262026-02-13
00850063404112easycare3200-100303200-100302026-02-13
00850063404136easycare3200-100323200-100322026-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00630094049212Bioseal Inc.BIOSEALGAX2024-01-25
00630094049229Bioseal Inc.BIOSEALGAX2024-01-25
00630094049236Bioseal Inc.BIOSEALGAX2024-01-25
00630094049243Bioseal Inc.BIOSEALGAX2024-01-25
00630094049045Bioseal Inc.BIOSEALGAX2024-01-24
00630094049069Bioseal Inc.BIOSEALGAX2024-01-24
00630094049076Bioseal Inc.BIOSEALGAX2024-01-24
00630094049083Bioseal Inc.BIOSEALGAX2024-01-24
00630094049090Bioseal Inc.BIOSEALGAX2024-01-24
00630094049106Bioseal Inc.BIOSEALGAX2024-01-24
00630094049120Bioseal Inc.BIOSEALGAX2024-01-24