iHealth

Primary DI
10850044118431
Brand
iHealth
Company
IHEALTH LAB INC.
Model
ICF-3000
Published
2024-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
QPKEua Faceshields

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QPKEua FaceshieldsUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850044118431PackageGS11In Commercial Distribution
20850044118438PackageGS12In Commercial Distribution
30850044118435PackageGS148In Commercial Distribution
00850044118434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004411843110850044118431
2085004411843820850044118438
3085004411843530850044118435
00850044118434008500441184348500441184340850044118434

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testingA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
054953337
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850078377224iHealthICR-30002026-01-30
10850078377095iHealthICR-30002026-01-02
10850078377101iHealthICR-30002026-01-02
10850078377125iHealthICR-30002026-01-02
10850078377132iHealthICR-30002026-01-02
10850044118691iHealthPT2L2025-12-19
10850044118707iHealthPT9L2025-12-19
10850044118721iHealthPT9L2025-12-19
10850044118776iHealthBG5S2025-12-19
10850044118806iHealthAG-6072025-12-19
10850078377088iHealthKN-550BT2025-12-19
10856362005156iHealthBG5SKIT2025-12-19
10856362005392iHealthKN-550BT2025-12-19
10850044118967iHealthBP-300CL2025-12-10
10856362005149iHealthBP5S2025-03-03
10850044118844iHealth3.6g*902024-11-18
10850044118868iHealthANC12024-10-30
10850044118783iHealthF50432024-09-28
10850044118233iHealthBG5SKIT2024-05-28
10850044118240iHealthBG5SKIT2024-05-27