MACOSEAL LIGHT

GUDID 03567050073097

MacoSeal LIGHT is a cordless, automatic, and portable tube sealer, designed for sealing tubing of blood bags systems. This sealer can be used in both fixed and mobile collection sites, as well as in preparation sites, to hermetically seal PVC tubing in an automatic operation that ensures the reproducible quality, width and separation of sealings. It is composed of three (3) mobile parts sold together, not separately.

MACO PRODUCTIONS

Blood donor bag tube divider/sealer
Primary Device ID03567050073097
NIH Device Record Keyd1323242-8823-4737-8e69-3c2acdcabef5
Commercial Distribution StatusIn Commercial Distribution
Brand NameMACOSEAL LIGHT
Version Model Number9MSLIGHT00
Company DUNS265492868
Company NameMACO PRODUCTIONS
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103567050073097 [Primary]

FDA Product Code

KSDDevice, Heat-Sealing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-04
Device Publish Date2024-08-27

Devices Manufactured by MACO PRODUCTIONS

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13567050052747 - VSE3010XD - Empty Bag 300 mL 6-Way Man2025-02-12 300 mL Empty Bag for Pooling of Blood Components.
13567050069684 - VSE8004XD - Empty Bag 600 mL 6-Way Man2025-02-12 600 mL Empty Bag for Pooling of Blood Components.
13567050069905 - VQE2001XD - 4 Empty Bags 300 mL2025-02-12 300ml Quad Splitting Empty Bags.
13567050070314 - VSL7001PD - Therapeutic Phlebotomy Bag w/Needle2025-02-12 600 mL Phlebotomy Bag with Needle.
13567050070321 - VSL7000YD - Therapeutic Phlebotomy Bag2025-02-12 600 mL Phlebotomy Bag with Luer Lock.
03567050071970 - MacoSeal PS2-AS2025-02-12 The MacoSeal PS2-AS is a portable and fully automatic system for sealing PVC tubes, especially tubes in blood pack systems. It p
03567051503227 - MacoMix HM20 and Hemolog 62025-02-12 The MacoMix HM20 device and optional Hemolog 6 software system is an automated blood mixer used during blood donation to mix the

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