FDA.reportPublic FDA data

Spiroguard

Primary DI
35060120951671
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
Rx
false
OTC
false
Sterile
false
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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
769934225
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
15060120951677Spiroguard 2800/21BAUC001/00012016-09-23
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

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Primary DI, Brand, Company table
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