Primary Device ID | 30327437026016 |
NIH Device Record Key | 3b184525-1d51-4214-8edc-f20e30e77a28 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Inspirachamber with SootherMask (medium) and InspiraMask (medium) |
Version Model Number | IPX1026 |
Company DUNS | 089153071 |
Company Name | LUPIN PHARMACEUTICALS, INC. |
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 | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 1-800-399-2561 |
info@askram.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00327437026015 [Primary] |
GS1 | 30327437026016 [Package] Contains: 00327437026015 Package: Shipper [10 Units] In Commercial Distribution |
NVP | Holding Chambers, Direct Patient Interface |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-09-09 |
Device Publish Date | 2019-08-30 |
00327437024011 - InspiraChamber Anti-static Valved Holding Chamber | 2019-09-09 InspiraChamber Anti-static Valved Holding Chamber (Retail Unit) |
30327437025019 - Inspirachamber with SootherMask (small) and InspiraMask (small) | 2019-09-09 Inspirachamber Anti-static Valved Holding Chamber with SootherMask (small) and InspiraMask (small) (Retail Unit) |
30327437026016 - Inspirachamber with SootherMask (medium) and InspiraMask (medium) | 2019-09-09Inspirachamber Anti-static Valved Holding Chamber with SootherMask (medium) and InspiraMask (medium) (Retail Unit) |
30327437026016 - Inspirachamber with SootherMask (medium) and InspiraMask (medium) | 2019-09-09 Inspirachamber Anti-static Valved Holding Chamber with SootherMask (medium) and InspiraMask (medium) (Retail Unit) |
30327437043013 - Inspirachamber with Inspiramask (Large) | 2019-09-09 Inspirachamber Anti-static Valved Holding Chamber with InspiraMask (Large) (Retail Unit) |