FDA.report

MiniMe Pediatric Mask with Headgear, Size Small

Primary DI
00814747024614
Brand
MiniMe Pediatric Mask with Headgear, Size Small
Company
SLEEPNET, CORP.
Model
60213
Device description
Pediatric nasal vented mask for use in positive pressure ventilation.
Published
2025-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications

CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00814747023020PreviousGS10
00814747024614PrimaryGS10

GMDN Terms

TermDefinition
CPAP/BPAP nasal mask, reusableA flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods

Method

Regulatory Flags

DUNS number
785635186
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00814747024690Arie Nasal Vented Mask, Large501512026-03-04
00814747024706Arie Nasal Vented Mask Kit501942026-03-04
00814747024713Arie Full Face Vented Mask, Small508042026-03-04
00814747024720Arie Full Face Vented Mask, Medium508052026-03-04
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00814747024744Arie Full Face Vented Mask Kit508512026-03-04
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00814747024638MiniMe Pediatric Mask with Headgear, Size Large602152025-05-06
00814747024645MiniMe Pediatric Ventilation Mask with Headgear, Size Small602532025-05-06
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10814747024390Novaplus Full Face Non Vented Mask, Small509162025-02-04
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10814747024420Novaplus Full Face Non Vented Mask, Extra Large509192025-02-04

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00814747024690Arie Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-03-04
00814747024706Arie Nasal Vented Mask KitSLEEPNET, CORP.BZD2026-03-04
00814747024713Arie Full Face Vented Mask, SmallSLEEPNET, CORP.BZD2026-03-04
00814747024720Arie Full Face Vented Mask, MediumSLEEPNET, CORP.BZD2026-03-04
00814747024737Arie Full Face Vented Mask, LargeSLEEPNET, CORP.BZD2026-03-04
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