FDA.reportPublic FDA data

Spiroguard

Primary DI
15060120951677
Brand
Spiroguard
Company
GVS FILTER TECHNOLOGY UK LTD
Model
2800/21BAUC001/0001
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
BZGSpirometer, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051712000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051712000MODEL 2800 PFT FILTERAir Safety, Ltd.2005-09-01BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
25060120951674PackageGS150In Commercial Distribution
35060120951671PackageGS1200In Commercial Distribution
15060120951677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2506012095167425060120951674
3506012095167135060120951671
1506012095167715060120951677

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function testing filter/mouthpieceA non-sterile, portable, screening device intended to be used during pulmonary function testing to remove and retain microdroplets from patient breath to reduce contamination of the parent device; it is also intended to function as a mouthpiece to facilitate access to the patient’s respiratory tract. It is a bidirectional filter, typically in a plastic housing, with a proximal port/mouthpiece; it may have a basic mouthpiece portion capable of being attached to a separate dedicated mouthpiece. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-5 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
769934225
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060120950694Insufflation Set6421/04BPKBTU001/00012026-02-20
25060120950691Insufflation Set6421/04BPKBTU001/00012026-02-20
05060120956415Nose ClipA5082026-02-10
15060120956412Nose ClipA5082026-02-10
15060120950106ECO HMEF4331/01BAUA001/00012016-09-23
15060120950779ECO Maxi Filter4222/701BAUA001/00012016-09-23
15060120951967Neo-natal HMEF9080/100BAUA001/00012016-09-23
15060120952490Multi-vent3000/07DAUA001/00012016-09-23
15060120952520L4 New Intake Filter3200/06AIUA058/00012016-09-23
15060120952537Respironics Domed (Gherkin)3400/01AIUA058/00012016-09-23
15060120952544Tyco-Achieva Bulk3500/01BAUA001/00012016-09-23
15060120952551Inogen3700/02BAUD001/00012016-09-23
15060120952568Maxi-Pleat6888/20BAUA001/00012016-09-23
15060120952575ECO Range4222/02BAUA001/00012016-09-23
15060120952582Standard HME6200/51BAUA069/00012016-09-23
15060120952599Standard HMEF6200/300BAUA069/00012016-09-23
15060120952605High Deadspace Body3888/01BIUA019/00012016-09-23
05060120956293Multi-Vent3000/03DAUA101/00012018-11-30
05060120957740HEPA Ventilation Filter4020/03ABMA001/00012020-06-26
15060120950571Insufflation Filter6421/04BAUA001/00016421/042025-12-11

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Primary DI, Brand, Company table
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