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Macy Catheter

FDA UDI

Class II (US FDA UDI)

by Hospi Corporation

Identity

Trade Name
Macy Catheter FDA UDI
Generic Name
Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
Device Name
The Macy Catheter is intended to provide rectal access to administer liquids/medications. FDA UDI
Model / Reference
E FDA UDI
Description
The Macy Catheter is intended to provide rectal access to administer liquids/medications. FDA UDI

Identifiers

Catalog Number
MAC-1001 FDA UDI
Primary DI / UDI-DI
00861003000202 FDA UDI
510(k) Number
K133881 FDA UDI
FDA Product Code
KNT FDA UDI
GMDN Term
Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5980 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Gastrointestinal/biliary dilation balloon catheter, non-medicated

Macy Catheter by Hospi Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrointestinal/biliary dilation balloon catheter, non-medicated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hospi Corporation

Sources (1)

  • FDA UDI 678d79ec-6ad3-422f-bcc5-dc012351ee34 36 fields · synced May 30, 2026