Primary Device ID | M52557700030 |
NIH Device Record Key | 237c535e-118c-4741-a992-0f00cdb192b5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Actalyke XL, (CSA/CE), New Display #2 (110V/220V) |
Version Model Number | 5770003 |
Company DUNS | 836287433 |
Company Name | HELENA LABORATORIES CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | false |
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 | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com | |
Phone | +1(800)231-5663 |
helena@helena.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M52557700030 [Primary] |
JBP | ACTIVATED WHOLE BLOOD CLOTTING TIME |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2023-09-11 |
Device Publish Date | 2016-08-22 |