FDA.reportPublic FDA data

SPIRO

Primary DI
07350061230353
Brand
SPIRO
Company
Fogless International AB
Model
XXX
Published
2023-09-21
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOHTube Tracheostomy And Tube Cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOHTube Tracheostomy And Tube CuffAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122932000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122932000SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORTFogless International AB2013-12-23JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350061230353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350061230353073500612303537350061230353

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube speech valveA device designed to be attached to a tracheostomy tube to eliminate the necessity of finger occlusion during speech, enabling the tracheostomized patient to speak easily and more clearly. It is typically intended to be regularly attached and removed by the patient (e.g., before and after sleeping). It may be made of metal [e.g., silver (Ag)] or plastic materials, and some types may have a sideport for connection to an oxygen supply. This is a single-patient device that may be reapplied over a period of time before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dark and dry environment at normal indoor room temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4636144100mail@fogless.se

Regulatory Flags#

DUNS number
356432815
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350061231220SPIRO730730-2K2018-03-31
07350061231008SPIRO702702-2K; 702-5K;2018-03-31
07350061231046SPIRO703703-2K2018-03-31
07350061231121SPIRO710710-1K; 710-2K; 710-5K2018-03-31
07350061231152SPIRO710R710R-1K; 710R-2K; 710R-5K2018-03-31
07350061231183SPIRO711711-1K; 711-2K; 711-5K;2018-03-31
07350061231268SPIRO760760-1K; 760-1KF2018-03-31
07350061231350SPIRO 740740-25K; 740-100K2018-03-31
07350061231060SPIRO705705-102018-03-31
07350061231084SPIRO707707-102018-03-31
07350061231107SPIRO708708-102018-03-31
07350061231091SPIRO707707-102018-03-31
07350061231114SPIRO708708-102018-03-31
07350061231237SPIRO730730-102018-03-31
07350061231077SPIRO705705-102018-03-31
07350061231282SPIRO7707702018-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10887709201610BivonaICU MEDICAL, INC.JOH2026-08-19
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