FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106513277
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
AMN410130B
Catalog number
AMN410130B
Device description
KIT, ER COMFORT
Published
2024-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LRAHearing aid, tactile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRAHearing Aid, TactileUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106513277PackageGS138In Commercial Distribution
10197106513279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710651327750197106513277
1019710651327910197106513279

GMDN Terms#

Term, Definition table
TermDefinition
Decontamination floor mat, single-useA pad made of coarse, durable material that is designed to be placed on the floor to wipe the soles of the footwear of persons walking on its surface. The product is intended to reduce the distribution of dirt/contaminated materials on the floor. The product is for single-use and is not washed or cleaned for reuse. It may be a pad of layered adhesive sheets that bind dirt touching the surface; when the sheet is sufficiently saturated it is peeled off and discarded to reveal a new adhesive surface.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956101357CARDINAL HEALTHCardinal Health 200, LLCLRA2025-06-05
10198956102637CARDINAL HEALTHCardinal Health 200, LLCLRA2025-06-05
50198956101355CARDINAL HEALTHCardinal Health 200, LLCLRA2025-06-05
50198956102635CARDINAL HEALTHCardinal Health 200, LLCLRA2025-06-05
10197106833261CARDINAL HEALTHCardinal Health 200, LLCLRA2024-12-10
10197106767566CARDINAL HEALTHCardinal Health 200, LLCLRA2024-10-15
50197106767564CARDINAL HEALTHCardinal Health 200, LLCLRA2024-10-15
10197106754641CARDINAL HEALTHCardinal Health 200, LLCLRA2024-09-27
50197106754649CARDINAL HEALTHCardinal Health 200, LLCLRA2024-09-27
10197106780855CARDINAL HEALTHCardinal Health 200, LLCLRA2024-09-24
50197106780853CARDINAL HEALTHCardinal Health 200, LLCLRA2024-09-24
10197106738931CARDINAL HEALTHCardinal Health 200, LLCLRA2024-08-21
50197106738939CARDINAL HEALTHCardinal Health 200, LLCLRA2024-08-21
10197106660010CARDINAL HEALTHCardinal Health 200, LLCLRA2024-07-05
10197106677438CARDINAL HEALTHCardinal Health 200, LLCLRA2024-07-05
50197106660018CARDINAL HEALTHCardinal Health 200, LLCLRA2024-07-05
50197106677436CARDINAL HEALTHCardinal Health 200, LLCLRA2024-07-05
10197106602065CARDINAL HEALTHCardinal Health 200, LLCLRA2024-04-24
50197106602063CARDINAL HEALTHCardinal Health 200, LLCLRA2024-04-24
10197106604434CARDINAL HEALTHCardinal Health 200, LLCLRA2024-03-20
50197106604432CARDINAL HEALTHCardinal Health 200, LLCLRA2024-03-20
10197106583982CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-15
50197106583980CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-15
10197106569122CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-12
10197106577585CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-12
50197106569120CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-12
50197106577583CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-12
10197106564394CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-02
50197106564392CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-02
10197106513279CARDINAL HEALTHCardinal Health 200, LLCLRA2024-01-23