FDA.reportPublic FDA data

Provox Swab Medium

Primary DI
07331791011429
Brand
Provox Swab Medium
Company
Atos Medical AB
Model
8251
Catalog number
8251
Published
2025-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EPEBRUSH, CLEANING, TRACHEAL TUBE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPEBrush, Cleaning, Tracheal TubeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07331791011429PrimaryGS10
07331791181320Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07331791011429073317910114297331791011429
07331791181320073317911813207331791181320

GMDN Terms#

Term, Definition table
TermDefinition
Airway device cleaning utensil, noninvasive, single-useA hand-held device intended to be used to clean an ex situ non-endoscopic airway device [e.g., endotracheal (ET) tube, tracheoesophageal speech valve, laryngeal airway], once it has been removed from the patient, to remove organic matter (e.g., phlegm). It is in the form of a flexible or rigid handle with distal soft or stiff bristles, fibres or spines, or a swab; it may be used in the home or healthcare facility. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from rain. Keep away from sunlight.
Storage Environment Temperature2 Degrees Celsius42 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit108 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+4641519800info@atosmedical.com

Regulatory Flags#

DUNS number
355470923
Device count
50
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07331791001611Provox Adhesive FlexiDerm Round725372532022-07-13
07331791001628Provox Adhesive FlexiDerm Oval725472542022-07-13
07331791001635Provox Adhesive OptiDerm Round725572552022-07-13
07331791001642Provox Adhesive OptiDerm Oval725672562022-07-13
07331791001703Provox XtraBase Adhesive726572652022-07-13
07331791008016Provox StabiliBase (15 pcs)728972892022-07-13
07331791008160Provox Adhesive FlexiDerm Plus733173312022-07-13
07331791008177Provox Adhesive OptiDerm Plus733273322022-07-13
07331791009037Provox StabiliBase OptiDerm (15 pcs)731873182022-07-13
07331791009259Provox Luna Adhesive801480142022-07-13
07331791009303Provox FreeHands Support Adhesive (15 pcs)802480242022-07-13
07331791009525Provox Adhesive Strip801580152022-07-13
07331791014420Provox Life Standard Adhesive Round746074602022-07-13
07331791014437Provox Life Standard Adhesive Oval746174612022-07-13
07331791014444Provox Life Standard Adhesive Plus746274622022-07-13
07331791014451Provox Life Sensitive Adhesive Round746374632022-07-13
07331791014468Provox Life Sensitive Adhesive Oval746474642022-07-13
07331791014475Provox Life Sensitive Adhesive Oval B746574652022-07-13
07331791014482Provox Life Sensitive Adhesive Plus746674662022-07-13
07331791014499Provox Life Stability Adhesive826382632022-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904428744954OSSEOUS- Tube Cleaning Brush - 8mmEON MEDITECH PRIVATE LIMITEDEPE2026-03-13
08904428798483OSSEOUS- Tube Cleaning Brush - 8mmEON MEDITECH PRIVATE LIMITEDEPE2026-03-13
07331791011412Provox Swab SmallAtos Medical ABEPE2025-10-24
07331791011436Provox Swab LargeAtos Medical ABEPE2025-10-24
07331791012730Provox Swab XtraLargeAtos Medical ABEPE2025-10-24
00848530085414CPAP Cleaning KitSUNSET HEALTHCARE SOLUTIONS, INC.EPE2025-04-14
00848253004013Cleaning Brush, StandardFreudenberg Medical, LLCEPE2025-03-25
00848253004020Cleaning Brush, LongFreudenberg Medical, LLCEPE2025-03-25
00348783005110Premier Tracheal Tube BrushPREMIER DENTAL PRODUCTS COMPANYEPE2024-08-06
00348783005127Premier Tracheal Tube BrushPREMIER DENTAL PRODUCTS COMPANYEPE2024-08-06
00848530085407CPAP TubingSUNSET HEALTHCARE SOLUTIONS, INC.EPE2024-06-19
00630094174044Bioseal Inc.BIOSEALEPE2023-09-18
00630094174099Bioseal Inc.BIOSEALEPE2023-09-18
10630094174041Bioseal Inc.BIOSEALEPE2023-09-18
10630094174096Bioseal Inc.BIOSEALEPE2023-09-18
07331791002656Provox TubeBrush 8 mmAtos Medical ABEPE2022-11-25
07331791002663Provox TubeBrush 12 mmAtos Medical ABEPE2022-11-25
07331791016493Provox TubeBrush 8 mmAtos Medical ABEPE2022-11-25
07331791016509Provox TubeBrush 12 mmAtos Medical ABEPE2022-11-25
14063107102674Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
14063107102681Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
14063107102698Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
14063107102704Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
34063107102678Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
34063107102685Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
34063107102692Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
34063107102708Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
10080196466863ML-CANADAMEDLINE INDUSTRIES, INC.EPE2022-01-01
00653160004755CenturionCENTURION MEDICAL PRODUCTS CORPORATIONEPE2022-01-01
50653160004750CenturionCENTURION MEDICAL PRODUCTS CORPORATIONEPE2022-01-01