FDA.report

NA

Primary DI
16948538360429
Brand
NA
Company
BMC Medical Co., Ltd.
Model
P2(SML)
Device description
Rio™ II Nasal Pillow Interface
Published
2017-11-15
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

Related Records

Contact Domains

Product Codes

CodeName
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications

CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Premarket Submissions

SubmissionSupplement
K112271000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K1122710003B WILLOW3B Products, LLC2012-02-16BZD

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16948538360429PackageGS115In Commercial Distribution
26948538360426PackageGS111In Commercial Distribution
36948538360423PackageGS129In Commercial Distribution
46948538360420PackageGS128In Commercial Distribution
56948538360427PackageGS130In Commercial Distribution
06948538360422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1694853836042916948538360429
2694853836042626948538360426
3694853836042336948538360423
4694853836042046948538360420
5694853836042756948538360427
06948538360422069485383604226948538360422

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.

Sterilization Methods

Method

Contacts

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

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16948538340193Siesta Contour Nasal MaskN5A+ (Extra Large)2026-02-02
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