FDA.reportPublic FDA data

Resp-O2 Disposable Suction Canisters

Primary DI
00840117313545
Brand
Resp-O2 Disposable Suction Canisters
Company
DYNAREX CORPORATION
Model
32201
Device description
Resp-O2 Disposable Suction Canisters, 800cc, Float Valve Shutoff, Locking Lid, 3/16" x 6' and 3/16" x 18" Tubing with Male Connector
Published
2022-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KDQBottle, Collection, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117313545PrimaryGS10
00840117322639Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117313545008401173135458401173135450840117313545
00840117322639008401173226398401173226390840117322639

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction system collection container, single-useA sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
12
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
false
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
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
00850027043821Precision Medical Inc.Precision Medical, Inc.KDQ2026-02-25
00850027043838Precision Medical Inc.Precision Medical, Inc.KDQ2026-02-25
00650862199109AtriumAtrium Medical CorporationKDQ2026-02-10
20650862199158AtriumAtrium Medical CorporationKDQ2026-02-10
20650862199189AtriumAtrium Medical CorporationKDQ2026-02-10
06970462546849Stone CollectorShenzhen HugeMed Medical Technical Development Co., Ltd.KDQ2026-02-10
16970462546853Stone CollectorShenzhen HugeMed Medical Technical Development Co., Ltd.KDQ2026-02-10
10884389968109MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
10884389968123MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
10888277143029MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
10888277143517MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
00860014577536GROWNSYOak Tech LLCKDQ2026-01-28
00860014577543GROWNSYOak Tech LLCKDQ2026-01-28
00810477022272AMPLIMAMPLIM, LLCKDQ2026-01-16
00810477022289AMPLIMAMPLIM, LLCKDQ2026-01-16
00810116023769Dornier HOOVER Access SheathDORNIER MEDTECH AMERICA, INC.KDQ2026-01-14
00810116023752Dornier HOOVER Access SheathDORNIER MEDTECH AMERICA, INC.KDQ2026-01-14
10884389968079MEDLINEMEDLINE INDUSTRIES, INC.KDQ2025-11-28
06976358503880SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KDQ2025-09-17
34026704912194PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-09-17
10858276007707Polyp Trap single chamber bulkMicro-tech UsaKDQ2025-09-09
34026704911784PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-09-04
26944932721962Wellead Stone Collection BottleWell Lead Medical Co.,LtdKDQ2025-08-14
06944932726215Wellead Stone Collection BottleWell Lead Medical Co.,LtdKDQ2025-08-14
26944932726226Wellead Stone Collection BottleWell Lead Medical Co.,LtdKDQ2025-08-14
50749756394418DeRoyalDEROYAL INDUSTRIES, INC.KDQ2025-08-13
06976472080106Nasal aspiratorShenzhen Dongjiang Technology Co., Ltd.KDQ2025-07-25
06976472080113Nasal aspiratorShenzhen Dongjiang Technology Co., Ltd.KDQ2025-07-25
06976472080151Nasal aspiratorShenzhen Dongjiang Technology Co., Ltd.KDQ2025-07-25
06976472080168Nasal aspiratorShenzhen Dongjiang Technology Co., Ltd.KDQ2025-07-25