FDA.reportPublic FDA data

MiniMe Pediatric Mask with Headgear, Size Medium

Primary DI
00814747024621
Brand
MiniMe Pediatric Mask with Headgear, Size Medium
Company
SLEEPNET, CORP.
Model
60214
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

Product Codes#

Code, Name table
CodeName
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814747023037PreviousGS10
00814747024621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814747023037008147470230378147470230370814747023037
00814747024621008147470246218147470246210814747024621

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
785635186
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814747024935MiniMe 2 Pediatric Nasal Vented Mask, Small602172026-06-22
00814747024942MiniMe 2 Pediatric Nasal Vented Mask, Large602212026-06-22
00814747024959MiniMe 2 Pediatric Nasal Non Vented Mask, Small602572026-06-22
00814747024966MiniMe 2 Pediatric Nasal Non Vented Mask, Large602612026-06-22
00814747024973Novaplus Pediatric Nasal Vented Mask, Small602232026-06-22
00814747024980Novaplus Pediatric Nasal Non Vented Mask, Small602502026-06-22
00814747024997Novaplus Pediatric Nasal Vented Mask, Large602252026-06-22
00814747025000Novaplus Pediatric Nasal Non Vented Mask, Large602522026-06-22
00814747024850Novaplus Pediatric Nasal Vented Mask, Extra Small602222026-06-03
00814747024867Novaplus Pediatric Nasal Vented Mask, Small602232026-06-03
00814747024874Novaplus Pediatric Nasal Vented Mask, Medium602242026-06-03
00814747024881Novaplus Pediatric Nasal Vented Mask, Large602252026-06-03
00814747024898Novaplus Pediatric Nasal Non Vented Mask, Extra Small602492026-06-03
00814747024904Novaplus Pediatric Nasal Non Vented Mask, Small602502026-06-03
00814747024911Novaplus Pediatric Nasal Non Vented Mask, Medium602512026-06-03
00814747024928Novaplus Pediatric Nasal Non Vented Mask, Large602522026-06-03
00814747024751MiniMe 2 Pediatric Nasal Vented Mask, Extra Small602162026-05-06
00814747024768MiniMe 2 Pediatric Nasal Vented Mask, Small602172026-05-06
00814747024775MiniMe 2 Pediatric Nasal Vented Mask, Medium602182026-05-06
00814747024782MiniMe 2 Pediatric Nasal Vented Mask, Large602212026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850088881097MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-24
00850088881103MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-24
00850088881035IBEETShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881042IBEETShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881059MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881066MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881028ItAllShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-09
00198843003347Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003361Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003385Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003408Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003422Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003545Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003552Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003569Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003576Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003583Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003590Infant Flow™Zoll Medical CorporationBZD2026-06-24
00814747024935MiniMe 2 Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024942MiniMe 2 Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747024959MiniMe 2 Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024966MiniMe 2 Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747024973Novaplus Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024980Novaplus Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024997Novaplus Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747025000Novaplus Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
04048675824121Seattle PAPDrägerwerk AG & Co. KGaABZD2026-06-11
00848530108984CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530108991CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109004CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04