I-neb 1052089

GUDID 00383730003627

I-neb TIM Mouthpiece Assembly.

RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Ultrasonic nebulizing system Ultrasonic nebulizing system Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated

• Primary Device ID: 00383730003627
• NIH Device Record Key: 99b7269f-403b-4d95-8a83-38b173f652c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I-neb
• Version Model Number: 00
• Catalog Number: 1052089
• Company DUNS: 220018415
• Company Name: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00383730003627 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102454

FDA Product Code

• CAF: NEBULIZER (DIRECT PATIENT INTERFACE)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-12
• Device Publish Date: 2016-08-24

On-Brand Devices [I-neb]

• 00383730004396: I-neb PH Unit Japan
• 00383730003931: I-NEB DISC.
• 00383730003832: I-neb 5.0 Chamber, 2 pack.
• 00383730003825: I-neb 2.5 Chamber, 2 pack.
• 00383730003818: I-neb 0.5 Tidal Breathing MP Chamber Assembly.
• 00383730003801: I-neb Chamber, 0.25 Tested.
• 00383730003795: I-neb Target Inhalation Mode MP.
• 00383730003788: I-neb Tidal Breathing Mode MP.
• 00383730003771: I-neb TBM MouthPiece Assembly Green Dnase Tested.
• 00383730003764: I-neb Chamber, 1.5 Tested.
• 00383730003757: I-neb Chamber, 0.3 Tested.
• 00383730003740: I-neb PH20 Gold Dosing Kit.
• 00383730003733: I-neb Charger.
• 00383730003726: I-neb CF TIM Pack, Europe.
• 00383730003719: I-neb PH Day Kit International Unit.
• 00383730003702: I-neb 5.0 mcg Gold Chamber, 2 pack.
• 00383730003696: I-neb PAH Day Kit US.
• 00383730003689: I-neb TIM MP Grey Chamber Assembly Tested.
• 00383730003672: I-neb TIM MP Lilac Chamber Assembly Tested.
• 00383730003665: I-neb TIM MP Green Chamber Assembly Tested.
• 00383730003658: I-neb Actelion PH 20 Dosing Kit.
• 00383730003641: I-neb Chamber Assembly for Hypertonic Saline.
• 00383730003634: I-neb CF Chamber Assembly Tobramycin.
• 00383730003627: I-neb TIM Mouthpiece Assembly.
• 00383730003610: I-neb Non-Metering TBM M-P White Tested.
• 00383730003603: I-neb Ventavis 5.0 mcg Purple PL6 Disc, US.
• 00383730003597: I-neb Ventavis 2.5 mcg Red Power 6 Disc, US.
• 00383730003580: I-neb Emergency Disc Assembly.
• 00383730003573: I-neb Disc Card Assembly Tadim.
• 00383730003566: I-neb Disc Card Assembly for Promixin.
• 00383730003559: I-neb Ventavis 5.0 mcg Concentrated Dose PL6.
• 00383730003542: I-neb GM-CSF PL15 Disc Assembly.
• 00383730003535: I-neb Emergency Disc Assembly, Blue.
• 00383730003528: I-neb Ventavis 5.0 mcg Purple Disc Assembly
• 00383730003511: I-neb Ventavis 2.5 mcg Red Disc Assembly
• 00383730003504: I-neb Disc Assy, Romedic.
• 00383730001005: I-neb Insight Online Multi-Lang Assembly
• 00383730000985: I-neb PH Australian Unit.
• 00383730000978: I-neb PH USA Unit.
• 00383730000961: I-neb PH UK Unit.
• 00383730000954: I-neb PH Middle East Unit.
• 00383730000947: I-neb CF TBM, TIM Unit Scandinavia.
• 00383730000930: I-neb CF TBM, TIM Unit Central Europe.
• 00383730000923: I-neb Handset Replacement.
• 00383730000916: I-neb CF TBM, TIM, Spain, Portugal Unit.
• 00383730000893: I-neb PH Latin America Unit.
• 00383730000886: I-neb PH Unit Europe South.
• 00383730000879: I-neb PH Unit Europe East.
• 00383730000862: I-neb PH Unit Europe Central.
• 00383730000848: I-neb CF German Unit.