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
10887709205274BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205519BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205526BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205533BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205793BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205809BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205816BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205823BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205830BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205595BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205601BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205618BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205625BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205632BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205649BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205656BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205663BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205670BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205700BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205717BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205724BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205731BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205748BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205755BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205762BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205779BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205786BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205281BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205298BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205304BivonaICU MEDICAL, INC.JOH2026-10-01