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Pediatric Plastic Disposable Mouthpiece

by Respironics Respiratory Drug Delivery (UK) Ltd

Ref HS715-100Model Peak Flow Meter Mouthpieces

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00383730004624 Basic UDI-DI 00383730004624UDI-DIDate18 Jul 2025RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number00383730004624 UDI-DI Date9 Jun 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Pediatric Plastic Disposable Mouthpiece EUDAMED
Plastic Pediatric Mouthpieces (715)100PK GUDID
Generic Name
Peak flow meter, manual
Model / Ref / Catalog
Peak Flow Meter Mouthpieces, HS715-100
Primary DI / UDI-DI
00383730004624
Basic UDI-DI
B-00383730004624
510(k) Number
FDA Product Code
BZH
EMDN Code
R9001 Respiratory mouthpieces
GMDN Term
Peak flow meter, manual
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
868.1860
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
GB-MF-000002292
Authorised representative
Philips Medical Systems Nederland B.V. NL-AR-000001422

Other devices from Respironics Respiratory Drug Delivery (UK) Ltd

See all devices from Respironics Respiratory Drug Delivery (UK) Ltd →

Properties

  • Single Use
  • Over-the-Counter
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No