InspiraChamber Valved Holding Chamber

Primary DI
10852367007126
Brand
InspiraChamber Valved Holding Chamber
Company
INSPIRX, INC
Model
1001-10L
Device description
InspiraChamber with InspiraMask (Large) (Teleflex Medical) 1001-10L
Published
2019-12-11
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NVPHolding Chambers, Direct Patient Interface

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVPHolding Chambers, Direct Patient InterfaceAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852367007126PackageGS110In Commercial Distribution
00852367007129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085236700712610852367007126
00852367007129008523670071298523670071290852367007129

GMDN Terms#

Term, Definition table
TermDefinition
Medicine chamber spacer, reusableA device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. It is typically made of plastic materials and in the form of a small tube-like container. By holding the drug(s) after aerosolization (e.g., via an internal valve) this device reduces the direct delivery of large aerosolized particles which would otherwise deposit in the mouth/upper airway, but are intended for the lower airway. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-471-4990ronnie.toddywala@inspirxpharma.com

Regulatory Flags#

DUNS number
967174850
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
true
Expiration date on label
false
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
00852367007075InspiraChamber Valved Holding Chamber1001-10SS2019-12-11
00852367007129InspiraChamber Valved Holding Chamber1001-10L2019-12-11
00852367007136InspiraChamber Valved Holding Chamber1001-10SM2019-12-11
00852367007150InspiraChamber Valved Holding Chamber1001-10M2019-12-11
00852367007167InspiraChamber Valved Holding Chamber1001-10S2019-12-11
10852367007072InspiraChamber Valved Holding Chamber1001-10SS2019-12-11
10852367007133InspiraChamber Valved Holding Chamber1001-10SM2019-12-11
10852367007157InspiraChamber Valved Holding Chamber1001-10M2019-12-11
10852367007164InspiraChamber Valved Holding Chamber1001-10S2019-12-11
00852367007051InspiraChamber Valved Holding Chamber1001-102019-07-16
00852367007068InspiraChamber Valved Holding Chamber1001-502019-07-16
10852367007058InspiraChamber Valved Holding Chamber1001-102019-07-16
10852367007065InspiraChamber Valved Holding Chamber1001-502019-07-16
00852367007006InspiraChamber Valved Holding ChamberIC-VHC-02017-12-18
10852367007003InspiraChamber Valved Holding ChamberIC-VHC-02017-12-18
00852367007013Inspirachamber with InspiraMask (Large)IC-IML-02017-12-18
00852367007020Inspirachamber with SootherMask (Small) and InspiraMask (Small)IC-SMS-02017-12-01
00852367007037Inspirachamber with SootherMask (Medium) and InspiraMask (Medium)IC-SMM-02017-12-01

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