Primary Device ID | B628DSV2C0 |
NIH Device Record Key | d05ddd7c-8a84-4553-8e17-a89ccfd96625 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Docking Station V2C |
Version Model Number | V2C |
Catalog Number | DSV2C |
Company DUNS | 808473453 |
Company Name | APDM, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 503-445-7757 |
support@apdm.com |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B628DSV2C0 [Primary] |
ISD | Exerciser, Measuring |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2020-03-05 |
Device Publish Date | 2019-12-30 |
B628APV2C0 - Access Point V2C | 2020-03-05 APDM’s Access Point is an accessory that enables wireless streaming to a computer for the Opal V2C. |
B628DSV2C0 - Docking Station V2C | 2020-03-05APDM’s Docking Station is an accessory that transfers the raw sensor data logged to a computer for the Opal V2C. Additionally, the Docking Station recharges the battery of an Opal V2C. |
B628DSV2C0 - Docking Station V2C | 2020-03-05 APDM’s Docking Station is an accessory that transfers the raw sensor data logged to a computer for the Opal V2C. Additionally, |
B628OPALV2C0 - Opal V2C | 2020-03-05 APDM's Opal V2C is a small worn monitor designed for documenting physical movement associated with applications in physiological |