CP Disposable Kit with 45mm Lightning Needle

GUDID M896CLPTPK101451

Cell Point Disposable Kit with 45mm Lightning Needle

ARTERIOCYTE MEDICAL SYSTEMS, INC.

Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration
Primary Device IDM896CLPTPK101451
NIH Device Record Key75154cda-c899-4eaa-8f4c-7266b2feb358
Commercial Distribution StatusIn Commercial Distribution
Brand NameCP Disposable Kit with 45mm Lightning Needle
Version Model NumberCLPT-PK-101-45
Company DUNS809012870
Company NameARTERIOCYTE MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone508-435-7412
Emailcustomerservice@arteriocyte.com
Phone508-435-7412
Emailcustomerservice@arteriocyte.com
Phone508-435-7412
Emailcustomerservice@arteriocyte.com
Phone508-435-7412
Emailcustomerservice@arteriocyte.com
Phone508-435-7412
Emailcustomerservice@arteriocyte.com
Phone508-435-7412
Emailcustomerservice@arteriocyte.com
Phone508-435-7412
Emailcustomerservice@arteriocyte.com
Phone508-435-7412
Emailcustomerservice@arteriocyte.com
Phone508-435-7412
Emailcustomerservice@arteriocyte.com
Phone508-435-7412
Emailcustomerservice@arteriocyte.com
Phone508-435-7412
Emailcustomerservice@arteriocyte.com
Phone508-435-7412
Emailcustomerservice@arteriocyte.com
Phone508-435-7412
Emailcustomerservice@arteriocyte.com
Phone508-435-7412
Emailcustomerservice@arteriocyte.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM896CLPTPK101450 [Primary]
HIBCCM896CLPTPK101451 [Package]
Contains: M896CLPTPK101450
Package: [1 Units]
In Commercial Distribution

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-07-23
Device Publish Date2020-02-26

Devices Manufactured by ARTERIOCYTE MEDICAL SYSTEMS, INC.

M896IFLXMAX020 - Magellan Influx2023-06-14 MAR0 Kit with 2.5cc Influx Max
M896AMS500220500 - Precise 2023-06-07 Precise Separation Canister, 60 mL
M896AMS500220530 - Precise 2023-06-07 Precise Separation Canister, 60mL
M896AMS500220560 - Precise 2023-06-07 Precise Separation Canister, 60 mL
M896AMS500350500 - Precise 2023-06-07 Precise Separation Canister, 120 mL
M896AMS500350530 - Precise 2023-06-07 Precise Separation Canister, 120 mL
M896AMS500350560 - Precise 2023-06-07 Precise Separation Canister, 120 mL
M896PRCDIA0600 - Precise Diamond 2023-06-07 Precise Diamond - 60 mL LP Kit

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.