FDA.reportPublic FDA data

1410 NRBV

Primary DI
00817136026503
Brand
1410 NRBV
Company
HANS RUDOLPH, INC.
Model
1410
Catalog number
C313
Device description
1410 22OD PORTS LESS SST DSTOP
Published
2021-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
CBPValve, Non-Rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBPValve, Non-RebreathingAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817136026503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817136026503008171360265038171360265030817136026503

GMDN Terms#

Term, Definition table
TermDefinition
Non-rebreathing valve, reusableA non-sterile device that is a one-way valve used to direct the flow of breathing gases and prevent the patient rebreathing the exhaled gases. It is typically used in a breathing system or between an oxygen mask and its reservoir bag. The device may be of various designs and will typically include unidirectional valves made of, e.g., silicone, rubber, metal, mica, sheets or discs that open and close for each inspiration/expiration. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007131725
Device count
1
DM exempt
true
Premarket exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008171360277157450 RV2 MASK74502018412025-09-19
008171360276927450 RV2 MASK74501138822024-07-15
008171360277087450 RV2 MASK74501138852024-07-15
008171360276855530 3L SYRINGE5530CR20972024-07-02
008171360276615570 3L SYRINGE55701136212023-11-08
008171360276545570 3L SYRINGE55701139272023-08-21
008171360276475570 3L SYRINGE55701139282023-08-17
008171360276307450 RV2 MASK7450CC16022023-08-11
008171360276237000 CONNECTORS7000CC17062023-06-14
008171360267637000 CONNECTORS7000CC20862023-06-13
008171360276167450 RV2 MASK7450CC21002023-04-13
008171360276092700 NRBV2700CR20872023-04-07
008171360270677450 RV2 MASK7450DR1320A2023-04-05
008171360270747450 RV2 MASK7450CC20812023-04-05
008171360270817450 RV2 MASK7450CC20822023-04-05
008171360270987450 RV2 MASK7450CC17432023-04-05
008171360271047450 RV2 MASK7450CC20512023-04-05
008171360271117450 RV2 MASK7450DR1320C2023-04-05
008171360271287450 RV2 MASK7450CC18592023-04-05
008171360271357450 RV2 MASK74502018302023-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B448FS1040Seal QuikFirstar Healthcare Company Limited (Guangzhou)CBP2025-12-10
16946430423013Lightning X Products, IncXIAMEN COMPOWER MEDICAL TECH. CO., LTDCBP2025-06-14
0503026716528522MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVEIntersurgical IncorporatedCBP2025-04-15
30889483570566AirLife™Sunmed Group Holdings, LLCCBP2025-03-28
16946430421941MENDYOUMEDICALXIAMEN COMPOWER MEDICAL TECH. CO., LTDCBP2024-11-26
00850055775022BIG EASY, NON-REBREATHING VALVEINNOVATION INSTITUTE, LLCCBP2024-10-30
0503026704086522MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM. 1.6MIntersurgical IncorporatedCBP2024-09-16
09420012480149Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCBP2024-09-11
04719871890011WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890028WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890042WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890059WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890066ARCFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890073WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890080FukuokaFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890097WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890103WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890110LIFEGUARDFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890608WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890615MEDSTORMFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890622LIFEGUARDFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890639WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890646WorldPointFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890653SoutheasternFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890677FirehouseFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890691FOREMOUNTFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890707WorldPointFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890714Top SafetyFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890721Top SafetyFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890738WorldPointFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28