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MiniMe 2 Pediatric Nasal Vented Mask, Extra Small

FDA UDI

Class II (US FDA UDI)

by Sleepnet Corporation

Identity

Trade Name
MiniMe 2 Pediatric Nasal Vented Mask, Extra Small FDA UDI
Generic Name
CPAP/BPAP nasal mask, reusable FDA UDI
Device Name
Pediatric nasal vented mask for use in positive pressure ventilation. FDA UDI
Model / Reference
60216 FDA UDI
Description
Pediatric nasal vented mask for use in positive pressure ventilation. FDA UDI

Identifiers

Primary DI / UDI-DI
00814747022191 FDA UDI
FDA Product Code
BZD FDA UDI
GMDN Term
CPAP/BPAP nasal mask, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5905 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: CPAP/BPAP nasal mask, reusable

MiniMe 2 Pediatric Nasal Vented Mask, Extra Small by Sleepnet Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as CPAP/BPAP nasal mask, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sleepnet Corporation

Sources (1)

  • FDA UDI 35f2ce85-8e81-4228-a2b6-4ed329c79f4c 33 fields · synced Jun 9, 2026