FDA.reportPublic FDA data

VYGON

Primary DI
53660812131273
Brand
VYGON
Company
VYGON
Model
535.05
Catalog number
00053505
Device description
Control suction catheter - Ø1.7mm - 05Fr - L.290mm
Published
2021-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSYCatheters, Suction, TracheobronchialAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
33660812131279PackageGS150In Commercial Distribution
53660812131273PackageGS19In Commercial Distribution
03660812131278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3366081213127933660812131279
5366081213127353660812131273
03660812131278036608121312783660812131278

GMDN Terms#

Term, Definition table
TermDefinition
Airway suction catheterA flexible tube designed to be inserted through the mouth, artificial airway, tracheostomy tube, and/or nostrils, for periodic aspiration of liquids and/or semi-solids from a patient's airway (e.g., pharynx, trachea, bronchi, nasal cavity) as part of a suction system; it is not intended to inflate the lungs. It is typically made of polymer with a smooth and rounded distal-tip, often including end and side holes and a finger-controlled valve to regulate suction. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
392994778
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
53660812094530VYGON368.47000368472025-03-31
33660812106628VYGON1366.167100136616712025-03-31
33660812114845VYGON1366.067100136606712025-03-31
53660812118915VYGON1366.107100136610712025-03-31
53660812118922VYGON1366.107200136610722025-03-31
53660812118946VYGON1366.087100136608712025-03-31
33660812118959VYGON1366.087200136608722025-03-31
53660812126392VYGON1366.127100136612712025-03-31
33660812126404VYGON1366.127200136612722025-03-31
53660812145324VYGON1362.127200136212722025-03-31
33660812145924VYGON1362.107100136210712025-03-31
53660812145935VYGON1362.107200136210722025-03-31
33660812147089VYGON1366.147100136614712025-03-31
53660812154227VYGON1362.067100136206712025-03-31
53660812145317VYGON1362.127100136212712025-03-20
53660812166541VYGON363.1270003631272025-03-20
33660812064881VYGON5249.7210052497212025-03-15
33660812073388VYGON5557.4500055574502025-03-15
33660812073395VYGON5557.5500055575502025-03-15
53660812073450VYGON81363.062F081363062F2025-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)Dynarex CorporationBSY2026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)Dynarex CorporationBSY2026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, 10 FR (3.3 mm)Dynarex CorporationBSY2026-05-25
20889483623562BALLARD™SUNMED, LLCBSY2026-01-16
00840117344136Resp-O2 Vortex 72 Closed Suction Tracheal Catheter,30.5 cm/12in, 12 FR (4.0 mm) Dynarex CorporationBSY2026-01-05
00840117344143Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 14 FR (4.6 mm),30.5 cm/12 inDynarex CorporationBSY2026-01-05
00840117344150Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 16 FR (5.3 mm),30.5 cm/12 inDynarex CorporationBSY2026-01-05
00840117344167Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 10 FR (3.3 mm),30.5 cm/12 inDynarex CorporationBSY2026-01-05
00840117344174Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 12 FR (4.0 mm),30.5 cm/12 inDynarex CorporationBSY2026-01-05
00840117344181Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 14 FR (4.6 mm),30.5 cm/12 inDynarex CorporationBSY2026-01-05
00840117344198Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 16 FR (5.3 mm),30.5 cm/12 inDynarex CorporationBSY2026-01-05
30889483563605BALLARD™SUNMED, LLCBSY2025-12-02
30889483563131BALLARD™SUNMED, LLCBSY2025-12-01
30889483563155BALLARD™SUNMED, LLCBSY2025-12-01
30889483563384BALLARD™SUNMED, LLCBSY2025-12-01
30889483563421BALLARD™SUNMED, LLCBSY2025-12-01
30889483564602BALLARD™SUNMED, LLCBSY2025-11-24
30889483564633BALLARD™SUNMED, LLCBSY2025-11-24
30889483564640BALLARD™SUNMED, LLCBSY2025-11-24
30889483564701BALLARD™SUNMED, LLCBSY2025-11-24
30889483564718BALLARD™SUNMED, LLCBSY2025-11-24
30889483564824BALLARD™SUNMED, LLCBSY2025-11-24
30889483567009BALLARD™SUNMED, LLCBSY2025-11-24
30889483623507BALLARD™SUNMED, LLCBSY2025-11-24
30889483623514BALLARD™SUNMED, LLCBSY2025-11-24
30889483626591BALLARD™SUNMED, LLCBSY2025-11-24
30889483562615BALLARD™SUNMED, LLCBSY2025-11-21
30889483623316BALLARD™SUNMED, LLCBSY2025-11-21
30889483623323BALLARD™SUNMED, LLCBSY2025-11-21
30889483623347BALLARD™SUNMED, LLCBSY2025-11-21