FDA.reportPublic FDA data

Tealmed

Primary DI
06974546525119
Brand
Tealmed
Company
Ningbo Tealmed Emergency Products Co., Ltd.
Model
#IS-5218
Published
2025-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ILHSplint, Hand, And Components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974546525119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974546525119069745465251196974546525119

GMDN Terms#

Term, Definition table
TermDefinition
First aid limb splint, mouldable, single-useA portable device intended to be used for emergency immobilization of an injured body extremity (arm or leg). It takes the form of a semi-rigid, padded, metallic sheet, or a wire frame, or a thermoplastic material designed to be manually moulded/curved externally around the limb to create a rigid splint. It is typically intended to be used by emergency medical services (EMS). This is a single-use device.

Regulatory Flags#

DUNS number
421289586
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974546523177Tealmed#DS-92992026-04-28
06974546525133Tealmed#IS-52242026-04-21
06974546524372Tealmed#DH-36952026-01-16
06974546525126Tealmed#IS-52092025-08-29
06974546523160Tealmed#DS9290-PK2025-07-21
06974546523153Tealmed#DS9290-BL2025-05-12
06974546525102Tealmed#IS-53242025-04-27
06974546527182Tealmed#KB-4137-W2025-03-20
06974546527175Tealmed#KB-10882024-12-16
06974546523122Tealmed#DS-92982024-09-23
06974546523139TealmedDS-9291-BK2024-09-23
06974546523146Tealmed#DS-9291-BL2024-09-23
06974546523115TealmedDS-9295-BR2024-08-20
06974546523108Tealmed#DS-92942024-07-31
06974546523092Tealmed#DS-9295-BK2024-06-25
06974546523078Tealmed#DS-9295-PU2024-05-06
06974546523085TealmedDS-9295-HG2024-05-06
06974546523061TealmedDS-9295-BL2024-04-10
06974546523054TealmedDS-9295-RD2024-03-13
06974546523047TealmedDS-9295-FG2024-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00057475274139BIOS LivingThermor LtdILH2023-09-18
00057475210175BIOS LivingThermor LtdILH2023-09-15
00057475210182BIOS LivingThermor LtdILH2023-09-15
10680651299854HalyardO&M HALYARD, INC.ILH2023-07-31
20680651299004HalyardO&M HALYARD, INC.ILH2023-06-07
00057475210441BIOS LivingThermor LtdILH2023-03-31
00057475210472BIOS LivingThermor LtdILH2023-03-31
00609271100053DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100152DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100251DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100350DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100459DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101050DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101159DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101258DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101357DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101456DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427006BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427013BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427020BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427037BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427044BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427051BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427068BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427075BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427082BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427099BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271610484SPLINT, WRIST, LACE-UP, RIGHT, X-SMALLDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271610491SPLINT, WRIST, LACE-UP, RIGHT, SMALLDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271610507SPLINT, WRIST, LACE-UP, RIGHT, MEDIUMDARCO INTERNATIONAL, INC.ILH2023-02-08