FDA.reportPublic FDA data

DRIVEMEDICAL

Primary DI
00822383127224
Brand
DRIVEMEDICAL
Company
Drive Devilbiss Healthcare
Model
CON 900
Device description
RespiratoryRespiratory Disposables Product Description: Water trap.O2 Conc.50/cs
Published
2019-06-21
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
false

Product Codes#

Code, Name table
CodeName
BYHDRAIN, TEE (WATER TRAP)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYHDrain, Tee (Water Trap)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822383127224PackageGS150In Commercial Distribution
50822383127229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383127224008223831272248223831272240822383127224
5082238312722950822383127229

GMDN Terms#

Term, Definition table
TermDefinition
Inspiratory/expiratory limb respiratory tubing, reusableA length of tube made of durable materials (e.g., rubber, silicone) intended to be used to conduct breathing gases towards or away from a patient during the respiratory cycle, typically during anaesthesia or ventilation [including continuous or bi-level positive airway pressure ventilation (CPAP or BPAP)]. It is intended to function as part of a breathing circuit and with other separate gas delivery devices (e.g., respiratory mask, connectors). This is a reusable device intended to be cleaned/disinfected prior to use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
867673159
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
00822383012155Silver Sport 16" ReclBackSSP16RBDDAV2026-02-03
00822383012162Silver Sport 16" Full ArmSSP16RBDFAV2026-02-03
00822383012179Silver Sport 18" Det DeskSSP18RBDDAV2026-02-03
00822383012186Silver Sport 18" Full ArmSSP18RBDFAV2026-02-03
00822383012193Silver Sport 20" Det DeskSSP20RBDDAV2026-02-03
00822383012209Silver Sport 20" Full ArmSSP20RBDFAV2026-02-03
00822383034683Silver Sport HD 22"SSP22RBDDAV2026-02-03
00822383034690Silver Sport 24" HDSSP24RBDDAV2026-02-03
00822383030135AeroFly Wheelchair, 18”, Black, SFAF18FDABK-SF2025-11-18
00822383030142AeroFly Wheelchair, 18”, Gray, SFAF18FDAGY-SF2025-11-18
00822383033204AeroFly Wheelchair 20:, Black, SFAF20FDABK-SF2025-11-11
00822383033211AeroFly Wheelchair 20:, Gray, SFAF20FDAGY-SF2025-11-11
00822383033228AeroFly Transport Chair, 18", BlackAFT18BK-SF2025-11-11
00822383033235AeroFly transport Chair, 18", GrayAFT18GY-SF2025-11-11
00822383030333DriveCFPC17FS2025-09-03
00822383000190Drive35BWBE-FM-SC0535BWBE-FM-SC052025-09-02
00822383000206Drive35MCBE-B-SC0535MCBE-B-SC052025-09-02
00822383000213Drive35MCBE-A-SC0535MCBE-A-SC052025-09-02
00822383000220Drive35MCBE-FM-SC0535MCBE-FM-SC052025-09-02
00822383000237Drive42BWBE-B-SC0542BWBE-B-SC052025-09-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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44710810119543N/AGALEMED CORPORATIONBYH2026-03-04
44710810119550N/AGALEMED CORPORATIONBYH2026-03-04
44710810119567N/AGALEMED CORPORATIONBYH2026-03-04
44710810119574N/AGALEMED CORPORATIONBYH2026-03-04
20197344011015HUDSON RCIMEDLINE INDUSTRIES, INC.BYH2025-08-18
30889483571914AirLife™Sunmed Group Holdings, LLCBYH2025-03-28
30889483570931AirLife™Sunmed Group Holdings, LLCBYH2025-03-18
30889483570955AirLife™Sunmed Group Holdings, LLCBYH2025-03-18
30889483570771AirLife™Sunmed Group Holdings, LLCBYH2025-02-20
30889483570788AirLife™Sunmed Group Holdings, LLCBYH2025-02-20
30889483570948AirLife™Sunmed Group Holdings, LLCBYH2025-02-20
30889483585751AirLife™Sunmed Group Holdings, LLCBYH2025-02-12
10840330705100ProCureTwin Med, LLCBYH2024-10-30
00026072024997BFAllied Medical, LLCBYH2024-10-11
00026072025383BFAllied Medical, LLCBYH2024-10-11
00092237614518ROSCOECOMPASS HEALTH BRANDS CORP.BYH2024-08-27
40026072012169BFAllied Medical, LLCBYH2024-05-28
00026072025000BFAllied Medical, LLCBYH2024-05-28
00026072025017BFAllied Medical, LLCBYH2024-05-28
10884521762183Microstream LuerORIDION MEDICAL 1987 LTD.BYH2023-09-04
04719872104124Water TrapENTER MEDICAL CORPORATIONBYH2023-06-19
34026704743378HUDSON RCITELEFLEX INCORPORATEDBYH2023-02-16
34026704743385HUDSON RCITELEFLEX INCORPORATEDBYH2023-02-16
34026704743392HUDSON RCITELEFLEX INCORPORATEDBYH2023-02-16
34026704743408HUDSON RCITELEFLEX INCORPORATEDBYH2023-02-16
50190752131109AirLife™VYAIRE MEDICAL, INC.BYH2022-09-05
50190752130515AirLife™VYAIRE MEDICAL, INC.BYH2022-08-22