FDA.reportPublic FDA data

Alleset

Primary DI
26931918142613
Brand
Alleset
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
TUF019
Device description
Arterial Pack_Sterile_2EA/CS
Published
2024-09-25
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
OEZCardiovascular Procedure Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26931918142613PackageGS12In Commercial Distribution
16931918142616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2693191814261326931918142613
1693191814261616931918142616

GMDN Terms#

Term, Definition table
TermDefinition
Non-dedicated vascular surgical procedure kitA collection of various surgical instruments and supportive devices/materials intended to support multiple types of vascular surgical/access procedures (non-dedicated); it is not intended to support a catheterization procedure. It typically includes devices such as syringes, needles, scalpel, swabs, dressings, and drapes; it does not include any pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+86057383617385linkdong@gri-china.com

Regulatory Flags#

DUNS number
679894738
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16931918100852Alleset80-08159-HB2026-07-28
16931918101774Alleset80-08158-HB2026-07-28
16931918103037Alleset80-08157-HB2026-07-28
16931918141121AllesetMV-13313-S2026-07-28
16931918145204AllesetMV-13103-S2026-07-28
16931918180090InvenioASI0012026-07-28
16931918183800InvenioMV-13323-S2026-07-28
16931918102214AllesetCS-32092026-07-16
16931918102948AllesetCS-1100HC2026-07-16
16931918107356AllesetCS-32182026-07-16
16931918106694InvenioGOL0292026-06-25
16931918107219InvenioGOL0372026-06-25
16931918100876Alleset80-01306T2026-06-04
16931918102450Alleset001-CAM0796PS2026-06-04
16931918104201Alleset001-BND0022S2026-06-04
16931918104416Alleset001-BND3636S2026-06-04
16931918104645Alleset80-01305T2026-06-04
16931918104843Alleset001-CARM24S2026-06-04
16931918104935Alleset001-BND3020S2026-06-04
16931918105239Alleset001-BND0018S2026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450376867Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-26
00884450431597Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-26
00884450432105Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-26
B098AMS195240Aligned Medical SolutionsAligned Medical SolutionsOEZ2026-09-26
10197106992753CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956169357CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956444263CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956466159CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956494923CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956529540CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956541566CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956547506CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956553835CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956562035CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956562820CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956570689CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956570863CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956577640CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956578388CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956580145CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956582439CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583283CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583320CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583412CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583665CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583726CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956584501CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956584518CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956584839CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956585201CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25