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Mr. Thirsty® One-Step Comfort Kit(10pk)

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 50Z992

by Zirc Dental Products Inc.

Identity

Trade Name
Mr. Thirsty® One-Step Comfort Kit(10pk) EUDAMED
Mr. Thirsty Comfort Kit FDA UDI
Generic Name
Dental suction system cannula, single-use FDA UDI
Device Name
Mr. Thirsty Comfort Kit EUDAMED
1 x HVE valve 1 x Comfort Kit HVE Connector 1 x Mr. Thirsty Tube FDA UDI
Model / Reference
50Z992 EUDAMEDFDA UDI
Description
1 x HVE valve 1 x Comfort Kit HVE Connector 1 x Mr. Thirsty Tube FDA UDI

Identifiers

Primary DI / UDI-DI
00840161304919 EUDAMEDFDA UDI
Basic UDI-DI
B-00840161304919 EUDAMED
FDA Product Code
DYN FDA UDI
EMDN Code
Q019001 SALIVA ASPIRATORS AND SALIVA ABSORBENTS EUDAMED
GMDN Term
Dental suction system cannula, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
872.6640 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 1.83 Meter FDA UDI

The Mr. Thirsty One-Step Comfort Kit from Medicom GmbH is a Class IIa medical device designed to provide comfort and relief for individuals with various conditions. It features an endocrine disruptor that has not been disclosed, as well as near-patient testing capabilities that have not been mentioned. The device is packaged in a container that may be identified as containing the device, but its specific contents are unknown.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Zirc Dental Products Inc.
EUDAMED SRN
US-MF-000021065
Authorised Representative
Medicom GmbH DE-AR-000005612

Sources (2)

  • EUDAMED 2895267b-b907-4a69-9745-2e3e04423e8b 61 fields · synced Jul 17, 2026
  • FDA UDI 78c77810-0360-40aa-8ab4-2a920e96da19 34 fields · synced May 30, 2026