FDA.reportPublic FDA data

MedSource Suction Catheter

Primary DI
00816703027585
Brand
MedSource Suction Catheter
Company
MEDSOURCE INTERNATIONAL LLC
Model
MS-SC10-RCS
Catalog number
Not Applicable
Device description
Suction Catheter, 10FR
Published
2021-08-12
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
00816703027585PackageGS150In Commercial Distribution
00816703027578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816703027585008167030275858167030275850816703027585
00816703027578008167030275788167030275780816703027578

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
041674552
Device count
1
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816703025475MedSource Emesis BagMS-17360-RCSNot Applicable2021-05-10
00816703026526MedSource Airway DevicesMS-23908-RCSNot Applicable2021-05-18
00816703027172MedSource Traction SplintMS-TLS-3-RCSNot Applicable2021-08-16
00816703020838MedSource PRN, Male Luer PrositeMS-830112016-06-30
00816703021118MedSource NP Needle Free ConnectorMS-899792016-06-30
00840155421042Nasopharyngeal Airway1011-450002025-07-15
00840155401419MedSource CathetersMS-87414Not Applicable2023-01-09
00840155406179MedSource CathetersMS-87416Not Applicable2023-01-09
00840155413870MedSource CathetersMS-87420Not Applicable2023-01-09
00840155413900MedSource CathetersMS-87422Not Applicable2023-01-09
00840155413931MedSource CathetersMS-87424Not Applicable2023-01-09
00840155413962MedSource CathetersMS-874202Not Applicable2023-01-09
00840155413993MedSource Winged CathetersMS-84214WNot Applicable2023-01-30
00840155414020MedSource Winged CathetersMS-84216WNot Applicable2023-01-30
00840155414051MedSource Winged CathetersMS-84218WNot Applicable2023-01-30
00840155414082MedSource Winged CathetersMS-842202WNot Applicable2023-01-30
00840155414112MedSource Winged CathetersMS-84220WNot Applicable2023-01-30
00840155414143MedSource Winged CathetersMS-84222WNot Applicable2023-01-30
00816703023129Elite CPR Face ShieldELITE-21105Not Applicable2021-04-20
00816703023143Elite CPR Face ShieldELITE-21106Not Applicable2021-04-20

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