Macy Catheter Bedside Care Kit MCK-1001

GUDID 00861003000219

Gastrointestinal/biliary dilation balloon catheter

Primary Device ID	00861003000219
NIH Device Record Key	0fec0a00-7451-4db3-a8c4-667993518869
Commercial Distribution Status	In Commercial Distribution
Brand Name	Macy Catheter Bedside Care Kit
Version Model Number	D
Catalog Number	MCK-1001
Company DUNS	068014556
Company Name	HOSPI CORPORATION
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	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00861003000219 [Primary]
GS1	10861003000216 [Package] Package: Box [10 Units] In Commercial Distribution

KDD	Kit, Surgical Instrument, Disposable

Steralize Prior To Use	false
Device Is Sterile	false

00861003000202 - Macy Catheter	2018-07-06 The Macy Catheter is intended to provide rectal access to administer liquids/medications.
00861003000219 - Macy Catheter Bedside Care Kit	2018-03-29Convenience kit for the Macy Catheter. Contents include: Macy Catheter, Liqui-Pill Assembly, Water Reservoir Assembly, 20ml Luer Lock Syringe, 3ml Exteral/Oral Syringe, 10ml Enteral/Oral Syringe, Macy Catheter Instructions for Use, Macy Catheter Bedside Care Kit Manual, Macy Catheter Medication Sheet (2), 3-Ply Poly Towel, Lubricating Jelly, Nitrile Gloves, Catheter Securing Device.
00861003000219 - Macy Catheter Bedside Care Kit	2018-03-29 Convenience kit for the Macy Catheter. Contents include: Macy Catheter, Liqui-Pill Assembly, Water Reservoir Assembly, 20ml Luer
00861003000226 - Macy Catheter Tray	2018-03-29 Convenience tray for the Macy Catheter. Contents include: Macy Catheter, 60ml Enteral/Oral Syringe, 10ml Enteral/Oral Syringe,