FDA.reportPublic FDA data

Seer Home

Primary DI
09355751001099
Brand
Seer Home
Company
SEER MEDICAL HOLDINGS LIMITED
Model
SM-01-9003-US
Device description
Take-home Kit
Published
2023-09-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PVPNeurological Test Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PVPNeurological Test KitNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09355751001099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09355751001099093557510010999355751001099

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic long-term ambulatory recording support kitA collection of non-sterile, noninvasive devices intended to be used in conjunction with an electrocardiographic (ECG) long-term ambulatory recorder (holter monitor) to facilitate recording. It includes an ECG electrode(s), batteries (to power the recorder), devices intended to assist electrode application (e.g., razor, electrode placement guide, conductive gel, skin cleaning wipe, tape), and may include other patient-supportive devices (e.g., diary/notebook); the recorder is not included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
744473197
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09355751001242Seer HomeSeer Cloud2024-06-27
09355751001174Seer HomeSM-01-80012024-06-27
09355751001181Seer HomeSM-03-8001-INT2024-06-27
09355751001228Seer HomeMonitoring Portal2024-06-27
09355751001235Seer HomeSeer App: Epilepsy Management2024-06-27
09355751001037Seer HomeSM-03-8001-INT2023-09-14
09355751001136Seer HomeMonitoring Portal2023-09-05
09355751001020Seer HomeSM-01-80012023-09-04
09355751001051Seer HomeSeer App: Epilepsy Management2023-09-04
09355751001211Seer HomeSM-07-80012024-06-27
09355751001259Seer HomeSM-01-90082024-06-27
09355751001266Seer HomeSM-01-90052024-06-27
09355751001105Seer HomeSM-01-90082023-09-14
09355751001112Seer HomeSM-01-90052023-09-05
09355751001129Seer HomeSM-07-80012023-06-21
19355751001218Seer HomeSM-07-80012024-06-27
09355751001273Seer HomeSM-01-90082024-06-27
09355751001044Seer HomeSeer Cloud2023-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956334458CARDINAL HEALTHCardinal Health 200, LLCPVP2026-02-23
50198956334456CARDINAL HEALTHCardinal Health 200, LLCPVP2026-02-23
10198956164697CARDINAL HEALTHCardinal Health 200, LLCPVP2025-08-08
50198956164695CARDINAL HEALTHCardinal Health 200, LLCPVP2025-08-08
10198956117358CARDINAL HEALTHCardinal Health 200, LLCPVP2025-06-20
50198956117356CARDINAL HEALTHCardinal Health 200, LLCPVP2025-06-20
10198956023512CARDINAL HEALTHCardinal Health 200, LLCPVP2025-03-31
50198956023510CARDINAL HEALTHCardinal Health 200, LLCPVP2025-03-31
10197106817032CARDINAL HEALTHCardinal Health 200, LLCPVP2024-12-04
50197106817030CARDINAL HEALTHCardinal Health 200, LLCPVP2024-12-04
10197106296653CARDINAL HEALTHCardinal Health 200, LLCPVP2023-08-30
50197106296651CARDINAL HEALTHCardinal Health 200, LLCPVP2023-08-30
10197106371404CARDINAL HEALTHCardinal Health 200, LLCPVP2023-07-24
50197106371402CARDINAL HEALTHCardinal Health 200, LLCPVP2023-07-24
10197106308073CARDINAL HEALTHCardinal Health 200, LLCPVP2023-06-20
50197106308071CARDINAL HEALTHCardinal Health 200, LLCPVP2023-06-20
10197106230671CARDINAL HEALTHCardinal Health 200, LLCPVP2023-04-21
50197106230679CARDINAL HEALTHCardinal Health 200, LLCPVP2023-04-21
10197106064580CARDINAL HEALTHCardinal Health 200, LLCPVP2023-01-25
10195594740795CARDINAL HEALTHCardinal Health 200, LLCPVP2022-07-08
50195594740793CARDINAL HEALTHCardinal Health 200, LLCPVP2022-07-08
10195594671471CARDINAL HEALTHCardinal Health 200, LLCPVP2022-05-26
50195594671479CARDINAL HEALTHCardinal Health 200, LLCPVP2022-05-26
10195594516246CARDINAL HEALTHCardinal Health 200, LLCPVP2022-04-29
50195594516244CARDINAL HEALTHCardinal Health 200, LLCPVP2022-04-29
10195594439880CARDINAL HEALTHCardinal Health 200, LLCPVP2021-11-30
50195594439888CARDINAL HEALTHCardinal Health 200, LLCPVP2021-11-30
10195594353926CARDINAL HEALTHCardinal Health 200, LLCPVP2021-10-12