Primary Device ID | 35020583514325 |
NIH Device Record Key | f683a493-23a7-4445-97cc-b162641c793e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ADI-25-02 ADIPREP Procedure Pack |
Version Model Number | 51432 |
Company DUNS | 801679200 |
Company Name | TERUMO BCT, INC. |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(303)205-2510 |
FDAUDIprogram@terumobct.com | |
Phone | +1(303)205-2510 |
FDAUDIprogram@terumobct.com |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 35020583514325 [Primary] |
MUU | System, suction, lipoplasty |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-08-23 |
Device Publish Date | 2016-09-15 |
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