FDA.reportPublic FDA data

Resp-O2 Closed Suction Endotracheal Catheter

Primary DI
00840117319769
Brand
Resp-O2 Closed Suction Endotracheal Catheter
Company
DYNAREX CORPORATION
Model
31023
Device description
Resp-O2 Closed Suction Endotracheal Catheter, 16FR w/ T-piece, Adult
Published
2021-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
00840117319516PackageGS12In Commercial Distribution
00840117319509PrimaryGS10
00840117319769Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117319516008401173195168401173195160840117319516
00840117319509008401173195098401173195090840117319509
00840117319769008401173197698401173197690840117319769

GMDN Terms#

Term, Definition table
TermDefinition
Closed-suction breathing circuit connector/switchA sterile length of tube with valves intended to create a closed three-way connection between an endotracheal tube, a ventilator/anaesthesia unit, and a suction pump to eliminate the need to disconnect the breathing circuit for secretion suctioning. The valves are intended to be manually-operated to isolate parts of the circuit and control suction, and the device may include a port(s) for the administration of fluids such as saline. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00616784709734Blood Pressure Cuff Kits, Sphygmomanometer, 3-Cuffs, Child, Adult, Large Adult70972017-11-21
00616784710327Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71032016-09-24
00616784710518Sphygmomanometer71052016-09-24
00616784710617Sphygmomanometer71062016-09-24
00616784711027Single Head Stethoscope, Single Head71102021-04-22
00616784711126Stethoscope Dual Head71112021-04-22
00616784711225PA SensiLance Pressure Activated Safety Lancets, Sterile71122021-05-21
00616784711423PA [SensiLance Pressure Activated Safety Lancets,Sterile71142021-05-21
00616784709833Blood Pressure Cuff Kits, Sphygmomanometer, 5-Cuffs, Infant, Child, Adult, Large70982017-11-21
00616784709529Digital Blood Pressure Monitor70952021-01-19
00616784709628Digital Blood Monitors70962021-01-19
00616784709925Blood Pressure Kit,Sphymomanometer with Dual Head Stethoscope70992016-09-24
00616784710020Blood Pressure Kit Sphygmomanometer with Stethoscope71002016-09-24
00616784710228Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71022016-09-24
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310612026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310622026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, 10 FR (3.3 mm)310632026-05-25
00840117349711IV Extension Sets Needle-Free Luer Lock Connector For Injection, Non-Toxic, 17"70612016-09-24
00840117349742IV Extension Sets Needle-Free Luer Lock Connector, Non-Toxic, 8" (20.3 cm)70622016-09-24
00616784706313IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic70632024-03-25

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