Primary Device ID | 00383730004563 |
NIH Device Record Key | ed54f2b8-6a3a-456f-8c6d-3755bba6cab9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ASTHMACHECK |
Version Model Number | HS002068-010 |
Catalog Number | HS002068-010 |
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 | false |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00383730004563 [Primary] |
BZH | METER, PEAK FLOW, SPIROMETRY |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-02-19 |
Device Publish Date | 2020-02-11 |
00383730004648 - OVAL MOUTHPIECE | 2020-06-19 OVAL MOUTHPIECE |
00383730004624 - PLASTIC PEDIATRIC MOUTHPIECES (715)100PK | 2020-06-17 PLASTIC PEDIATRIC MOUTHPIECES (715)100PK |
00383730004631 - PLASTIC PEDIATRIC DISPOSABLE MOUTHPIECE | 2020-06-17 PLASTIC PEDIATRIC DISPOSABLE MOUTHPIECE |
00383730004617 - OVAL DISPOSABLE PLASTIC MOUTHPIECE | 2020-06-15 OVAL DISPOSABLE PLASTIC MOUTHPIECE |
00383730004495 - TBM MP Gold Chamber Assy Tested | 2020-04-01 Tidal Breathing Mode Mouthpiece Gold Chamber Assembly Tested |
00383730004501 - I-neb Clinical Study Disc | 2020-04-01 I-neb Clinical Study Disc |
00383730004518 - I-neb Generic ClinicalStudy Disc Power10 | 2020-04-01 I-neb Generic Clinical Study Disc Power10 |
00383730004587 - I-neb In Vitro Test Disc Power 10 | 2020-04-01 I-neb In Vitro Test Disc Power 10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ASTHMACHECK 75265114 2187345 Live/Registered |
RESPIRONICS INC. 1997-03-27 |