PLASTIC PEDIATRIC MOUTHPIECES (715)100PK HS715-100

GUDID 00383730004624

PLASTIC PEDIATRIC MOUTHPIECES (715)100PK

RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Peak flow meter, manual Peak flow meter, manual Peak flow meter, manual Peak flow meter, manual Peak flow meter, manual Peak flow meter, manual Peak flow meter, manual Peak flow meter, manual Peak flow meter, manual Peak flow meter, manual Peak flow meter, manual Peak flow meter, manual Peak flow meter, manual Peak flow meter, manual Peak flow meter, manual
Primary Device ID00383730004624
NIH Device Record Keycf0549b2-1016-4973-a3c2-cbe74c4ea59f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePLASTIC PEDIATRIC MOUTHPIECES (715)100PK
Version Model NumberHS715-100
Catalog NumberHS715-100
Company DUNS220018415
Company NameRESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100383730004624 [Primary]
GS100383730004624 [Primary]
GS100383730004624 [Primary]
GS100383730004624 [Primary]
GS100383730004624 [Primary]
GS100383730004624 [Primary]
GS100383730004624 [Primary]
GS100383730004624 [Primary]
GS100383730004624 [Primary]
GS100383730004624 [Primary]
GS100383730004624 [Primary]
GS100383730004624 [Primary]
GS100383730004624 [Primary]
GS100383730004624 [Primary]
GS100383730004624 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZHMETER, PEAK FLOW, SPIROMETRY
BZHMETER, PEAK FLOW, SPIROMETRY
BZHMETER, PEAK FLOW, SPIROMETRY
BZHMETER, PEAK FLOW, SPIROMETRY
BZHMETER, PEAK FLOW, SPIROMETRY
BZHMETER, PEAK FLOW, SPIROMETRY
BZHMETER, PEAK FLOW, SPIROMETRY
BZHMETER, PEAK FLOW, SPIROMETRY
BZHMETER, PEAK FLOW, SPIROMETRY
BZHMETER, PEAK FLOW, SPIROMETRY
BZHMETER, PEAK FLOW, SPIROMETRY
BZHMETER, PEAK FLOW, SPIROMETRY
BZHMETER, PEAK FLOW, SPIROMETRY
BZHMETER, PEAK FLOW, SPIROMETRY
BZHMETER, PEAK FLOW, SPIROMETRY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-17
Device Publish Date2020-06-09

Devices Manufactured by RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

00383730004624 - PLASTIC PEDIATRIC MOUTHPIECES (715)100PK2020-06-17PLASTIC PEDIATRIC MOUTHPIECES (715)100PK
00383730004624 - PLASTIC PEDIATRIC MOUTHPIECES (715)100PK2020-06-17 PLASTIC PEDIATRIC MOUTHPIECES (715)100PK
00383730004631 - PLASTIC PEDIATRIC DISPOSABLE MOUTHPIECE2020-06-17 PLASTIC PEDIATRIC DISPOSABLE MOUTHPIECE
00383730004495 - TBM MP Gold Chamber Assy Tested2020-04-01 Tidal Breathing Mode Mouthpiece Gold Chamber Assembly Tested
00383730004501 - I-neb Clinical Study Disc2020-04-01 I-neb Clinical Study Disc
00383730004518 - I-neb Generic ClinicalStudy Disc Power102020-04-01 I-neb Generic Clinical Study Disc Power10
00383730004587 - I-neb In Vitro Test Disc Power 102020-04-01 I-neb In Vitro Test Disc Power 10
00383730004594 - I-neb In Vitro Test Disc Power 122020-04-01 I-neb In Vitro Test Disc Power 12
00383730004600 - I-neb In Vitro Test Disc Power 62020-04-01 I-neb In Vitro Test Disc Power 6

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