FDA.reportPublic FDA data

I -neb

Primary DI
00383730000992
Brand
I -neb
Company
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
Model
00
Catalog number
1055717
Device description
I-neb Insight TBM and TIM Unit
Published
2016-09-21
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
CAFNEBULIZER (DIRECT PATIENT INTERFACE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00383730000992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00383730000992003837300009923837300009920383730000992

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic nebulizing systemAn assembly of devices designed to generate aerosolized medication/fluids (finely dispersed airborne droplets) for inhalation by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It typically consists of a mains electricity (AC-powered) electronic oscillator, an ultrasound transducer (piezoelectric crystal), a coupling basin, a nebulizer chamber and a fan. A high frequency (e.g., 1-2 MHz) electrical current is applied to the crystal within the oscillator circuit converting it to vibrations which produce sound waves. The coupler (water or saline) transmits the sound waves to the medicated solution in the nebulizing chamber.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(724)744-2500respironics.service@philips.com

Regulatory Flags#

DUNS number
220018415
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
false
Expiration date on label
false
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
00383730004648OVAL MOUTHPIECE113696011369602020-06-11
00383730004624PLASTIC PEDIATRIC MOUTHPIECES (715)100PKHS715-100HS715-1002020-06-09
00383730004631PLASTIC PEDIATRIC DISPOSABLE MOUTHPIECEHS715HS7152020-06-09
00383730004617OVAL DISPOSABLE PLASTIC MOUTHPIECEHS757-100HS757-1002020-06-05
00383730004495TBM MP Gold Chamber Assy Tested1070291T1070291T2020-03-24
00383730004501I-neb Clinical Study Disc110416211041622020-03-24
00383730004518I-neb Generic ClinicalStudy Disc Power10112449811244982020-03-24
00383730004587I-neb In Vitro Test Disc Power 10100341910034192020-03-24
00383730004594I-neb In Vitro Test Disc Power 12100377810037782020-03-24
00383730004600I-neb In Vitro Test Disc Power 6110979711097972020-03-24
00383730002828InnoSpire Elegance0011205632016-08-24
00383730004563ASTHMACHECKHS002068-010HS002068-0102020-02-11
00383730004013INNOSPIRE ESSENCE112740911274092019-06-27
00383730003993Innospire Essence112954211295422019-06-17
00383730004006INNOSPIRE ESSENCE112953911295392019-06-17
00383730004037Innospire Essence112818211281822019-06-17
00383730004181ISG Handset and Mouthpiece Assy Russia0011341292019-06-17
00383730004372ACDC Power Adapter (AUNZ)0011353612019-06-17
00383730004389INNOSPIRE GO AUNZ0011353602019-06-17
00383730004419Innospire Elegance0011368252019-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00604351673106MC 300 Reusable NebulizerMonaghan Medical CorporationCAF2026-05-26
44710810080584N/AGALEMED CORPORATIONCAF2026-03-05
44710810082120N/AGALEMED CORPORATIONCAF2026-03-05
44710810082960N/AGALEMED CORPORATIONCAF2026-03-05
44710810084988N/AGALEMED CORPORATIONCAF2026-03-05
44710810085060N/AGALEMED CORPORATIONCAF2026-03-05
44710810085947N/AGALEMED CORPORATIONCAF2026-03-05
44710810086005N/AGALEMED CORPORATIONCAF2026-03-05
44710810088283N/AGALEMED CORPORATIONCAF2026-03-05
44710810088962N/AGALEMED CORPORATIONCAF2026-03-05
44710810089488N/AGALEMED CORPORATIONCAF2026-03-05
44710810110847N/AGALEMED CORPORATIONCAF2026-03-05
44710810112650N/AGALEMED CORPORATIONCAF2026-03-05
20889483230005VixOne™SUNMED, LLCCAF2026-02-11
00199874417059AirpulseAIRPULSE LTDCAF2026-02-03
00810178886371Vive BreatheVIVE HEALTH LLCCAF2026-02-02
00810178884049Vive BreatheVIVE HEALTH LLCCAF2026-01-30
00810178884681Vive BreatheVIVE HEALTH LLCCAF2026-01-30
00810178886814Vive BreatheVIVE HEALTH LLCCAF2026-01-30
04719873130153AdheRespHCMED INNOVATIONS CO., LTD.CAF2026-01-29
04719873130207Aerogen® Go HCMED INNOVATIONS CO., LTD.CAF2026-01-28
04719873130214Aerogen® Go HCMED INNOVATIONS CO., LTD.CAF2026-01-28
04719873130351Aerogen® Go HCMED INNOVATIONS CO., LTD.CAF2026-01-28
00848530107932Nebulizer and CompressorSUNSET HEALTHCARE SOLUTIONS, INC.CAF2026-01-26
04719873131228Aerogen® Go HCMED INNOVATIONS CO., LTD.CAF2026-01-22
04719873131235Pulmogine®HCMED INNOVATIONS CO., LTD.CAF2026-01-22
46923980103689N/AGaleMed Xiamen Co., Ltd.CAF2026-01-22
46923980105430N/AGaleMed Xiamen Co., Ltd.CAF2026-01-22
46923980105461N/AGaleMed Xiamen Co., Ltd.CAF2026-01-22
46923980105485N/AGaleMed Xiamen Co., Ltd.CAF2026-01-22