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PrimeAire

by Thayer Medical Corporation

Ref 1114

PrimeAire (1114) is a device classified as Class I in the EU and Class II in the US made by Thayer Medical Corporation, registered in EUDAMED on 21 Dec 2024 (Basic UDI-DI B-00383480000051), cleared under FDA 510(k) K992722 on 10 Nov 1999 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00383480000051), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K992722

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00383480000051 Basic UDI-DI 00383480000051UDI-DIDate21 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00383480000051 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK992722 Date10 Nov 1999DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00383480000051 registered 21 Dec 2024 Active
  • FDA 510(k) K992722 decided 10 Nov 1999 Active
  • FDA GUDID UDI-DI 00383480000051 listed 21 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K992722
  2. Listed FDA GUDID 00383480000051
  3. Registered EUDAMED B-00383480000051

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Medicine chamber spacer, reusable
Device name
PrimeAire Valved Holding Chamber
Model / Ref / Catalog
1114
Primary DI / UDI-DI
00383480000051
Basic UDI-DI
B-00383480000051
510(k) Number
FDA product code
CAF
EMDN code
R9080 Respiratory and anesthesia devices - accessories not included in other classes
GMDN term
Medicine chamber spacer, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
868.5630
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000026197
Authorised representative
MDSS GmbH DE-AR-000005430

Related devices

Category: Gas-sampling/monitoring respiratory tubing, single-use

Similar devices in this category

Other devices filed under RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES.

Other devices from Thayer Medical Corporation

See all devices from Thayer Medical Corporation →

Properties

  • Administering medicine
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)