FDA.reportPublic FDA data

T-MOUTHPIECE FOR CIRRUS NEBULISER

Primary DI
05030267002375
Brand
T-MOUTHPIECE FOR CIRRUS NEBULISER
Company
INTERSURGICAL INCORPORATED
Model
1510000
Device description
T-MOUTHPIECE FOR CIRRUS NEBULISER
Published
2021-10-12
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYPMouthpiece, Breathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYPMouthpiece, BreathingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05030267002375PackageGS175In Commercial Distribution
05030267053483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05030267002375050302670023755030267002375
05030267053483050302670534835030267053483

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing system delivery set, single-useA collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is made of synthetic material and is typically a thick-walled, anti-kink tubing to prevent blockage. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3154512900support@intersurgicalinc.com

Regulatory Flags#

DUNS number
785952607
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
05030267124084ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 0, NEONATE 15M122000051948502025-09-25
05030267124091ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 1, INFANT, 15M122100051948502025-09-25
05030267124107ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 2, PAEDIATRIC, 22F122200051948502025-09-25
05030267123582ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 3, SMALL ADULT, 22F122300051948502025-09-25
05030267124121ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 4, MEDIUM ADULT, 22F122400051948502025-09-25
05030267124077ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 5, LARGE ADULT, 22F122500051948502025-09-25
05030267124138ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 6, EXTRA LARGE ADULT, 22122600051948502025-09-25
05030267165322I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULT730000151948502025-09-23
05030267165346I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, MEDIUM ADULT730100151948502025-09-23
05030267165360HIGH FLOW NASAL CANNULA WITH ADAPTER, LARGE ADULT730200151948502025-09-23
0503026704595222MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE 519185051918502025-04-16
0503026704588422MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6M519485051948502025-04-16
05030267001804TRACHEOSTOMY MASK, PAEDIATRIC120600012060002025-04-15
05030267098088PREMATURE, NASAL CANNULA WITH CURVED PRONGS AND TUBE, 2.1M 116000011600002025-04-15
0503026716528522MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVE518301051830102025-04-15
00816472022552Nose Clip with Padding143560002025-04-14
0503026716154622mm Compact breathing system21580192025-04-14
0503026716175122mm Compact breathing system21580122025-04-14
05030267166367I-GEL® PLUS ANAESTHESIA, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG890300089030002025-04-14
05030267166466I-GEL® PLUS ANAESTHESIA, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG.890400089040002025-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904461055024OSSEOUS-SnorOFFEON MEDITECH PRIVATE LIMITEDBYP2026-03-13
46923980103672N/AGaleMed Xiamen Co., Ltd.BYP2025-12-23
20197344011312HUDSON RCIMEDLINE INDUSTRIES, INC.BYP2025-08-18
04250892907321JaegerJaeger Medical GmbHBYP2025-06-02
04250892907383JaegerJaeger Medical GmbHBYP2025-06-02
30889483573451AirLife™Sunmed Group Holdings, LLCBYP2025-03-27
30889483569164AirLife™Sunmed Group Holdings, LLCBYP2025-03-18
30889483569195AirLife™Sunmed Group Holdings, LLCBYP2025-03-18
00817081028232Mouthpiece, Disposable, White, Thermoplastic, Bite Block StyleA-M SYSTEMS, LLCBYP2025-02-21
00817081028256Breathebite Mouthpiece, Disposable, Thermoplastic, Tongue DepressingA-M SYSTEMS, LLCBYP2025-02-21
14250892906833VyaireVyaire Medical GmbHBYP2025-01-07
14250892906840VyaireVyaire Medical GmbHBYP2025-01-07
14250892906857VyaireVyaire Medical GmbHBYP2025-01-07
14250892906864VyaireVyaire Medical GmbHBYP2025-01-07
07613365500110SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
07613365500134SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
07613365500196SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
00026072026304BFAllied Medical, LLCBYP2024-10-11
08052990320219MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABYP2024-09-10
08052990321179MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABYP2024-09-10
08052990321834MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABYP2024-09-10
10197344103737MEDLINEMEDLINE INDUSTRIES, INC.BYP2024-07-22
00026072026243BFAllied Medical, LLCBYP2024-05-28
00026072026298BFAllied Medical, LLCBYP2024-05-28
B279F037005001Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
B279F037020002Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
B279S29807005001Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
B279S29807020002Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
00817081027686Adapter, Tube, Sample PackA-M SYSTEMS, LLCBYP2023-11-21
10384620000730InFloConeALLIANCE TECH MEDICAL INCBYP2023-09-08