Rio II Nasal Pillows Interface (without Headgear)-S

GUDID 16948538364182

Rio II Nasal Pillows Interface (without Headgear)-S

BMC Medical Co., Ltd.

CPAP/BPAP nasal mask, reusable
Primary Device ID16948538364182
NIH Device Record Key4a728d49-15ca-419a-b04d-2144a0ed6374
Commercial Distribution StatusIn Commercial Distribution
Brand NameRio II Nasal Pillows Interface (without Headgear)-S
Version Model NumberP2(Small)
Company DUNS526010310
Company NameBMC Medical Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106948538364185 [Primary]
GS116948538364182 [Package]
Contains: 06948538364185
Package: [65 Units]
In Commercial Distribution

FDA Product Code

BZDVentilator, Non-Continuous (Respirator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-19
Device Publish Date2023-04-11

Devices Manufactured by BMC Medical Co., Ltd.

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36948538368047 - Siesta 2 Nasal Mask2024-04-10 Siesta 2 Nasal Mask
36948538368054 - Siesta 2 Nasal Mask2024-04-10 Siesta 2 Nasal Mask
36948538368061 - Siesta 2 Nasal Mask2024-04-10 Siesta 2 Nasal Mask
36948538368078 - Siesta 2 Nasal Mask2024-04-10 Siesta 2 Nasal Mask
36948538368085 - Siesta 2 Full Face Mask2024-04-10 Siesta 2 Full Face Mask
36948538368092 - Siesta 2 Full Face Mask2024-04-10 Siesta 2 Full Face Mask
06948538368107 - Siesta 2 Full Face Mask2024-04-10 Siesta 2 Full Face Mask

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