FDA.reportPublic FDA data

io

Primary DI
16948538360115
Brand
io
Company
BMC Medical Co., Ltd.
Model
Size:Large
Device description
ioTM Mini Nasal Mask
Published
2016-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131901000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131901000IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N23B Medical, Inc.2013-12-23BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16948538360115PackageGS120In Commercial Distribution
06948538360118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694853836011516948538360115
06948538360118069485383601186948538360118

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-863-226-6285cpewitt@3Bproducts.com

Regulatory Flags#

DUNS number
526010310
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06948538362563Water ChamberWT-C12022-08-29
06948538340165Siesta Contour Nasal MaskN5A+ (Small)2026-02-02
06948538340172Siesta Contour Nasal MaskN5A+ (Medium)2026-02-02
06948538340189Siesta Contour Nasal MaskN5A+ (Large)2026-02-02
06948538340196Siesta Contour Nasal MaskN5A+ (Extra Large)2026-02-02
06948538340202Siesta Contour Nasal MaskN5A+ (All Size Kit)2026-02-02
06948538340219Siesta Contour Nasal MaskN5A+ (All Size Kit)-Sample2026-02-02
06948538340226Siesta Contour Nasal MaskN5A+ (Small)-Sleep Lab2026-02-02
06948538340233Siesta Contour Nasal MaskN5A+ (Medium)-Sleep Lab2026-02-02
06948538340240Siesta Contour Nasal MaskN5A+ (Large)-Sleep Lab2026-02-02
06948538340257Siesta Contour Nasal MaskN5A+ (Extra Large)-Sleep Lab2026-02-02
06948538340264Siesta Contour Nasal MaskN5A+ (All Size Kit)-Sleep Lab2026-02-02
16948538340162Siesta Contour Nasal MaskN5A+ (Small)2026-02-02
16948538340179Siesta Contour Nasal MaskN5A+ (Medium)2026-02-02
16948538340186Siesta Contour Nasal MaskN5A+ (Large)2026-02-02
16948538340193Siesta Contour Nasal MaskN5A+ (Extra Large)2026-02-02
16948538340209Siesta Contour Nasal MaskN5A+ (All Size Kit)2026-02-02
16948538340216Siesta Contour Nasal MaskN5A+ (All Size Kit)-Sample2026-02-02
16948538340223Siesta Contour Nasal MaskN5A+ (Small)-Sleep Lab2026-02-02
16948538340230Siesta Contour Nasal MaskN5A+ (Medium)-Sleep Lab2026-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530106461CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106478CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106485CPAP Mask CushionSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106492CPAP Mask CushionSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106508CPAP Mask CushionSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106515CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-07-17
00848530106355CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106362Nasal CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106379CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106386CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106393CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106409Nasal CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
10889483586358Vital Signs™AIRLIFEBZD2025-02-18
00848530081638CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530085230CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090661CPAP MaskSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090678CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090685CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090692CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090708CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090715CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090722CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090739CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090746CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097103CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097110CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097127CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097134CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097141CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097158CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29