FDA.report

DeRoyal

Primary DI
50749756872039
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
32-2062
Catalog number
32-2062
Device description
Connector & Tubing
Published
2023-03-03
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

Related Records

Product Codes

CodeName
BYXTUBING, PRESSURE AND ACCESSORIES

Product Code Classifications

CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50749756872039PackageGS125In Commercial Distribution
00749756872034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975687203950749756872039
00749756872034007497568720347497568720340749756872034

GMDN Terms

TermDefinition
Breathing circuit catheter mount, single-useA device designed to connect a respiratory circuit (e.g., an anaesthesia breathing circuit or ventilator breathing circuit) or a resuscitator to an endotracheal (ET) tube, to enable increased mobility at the patient end of the circuit or connections. It most commonly consists of a 22 mm female adaptor at the proximal end that is attached to a short length of corrugated, flexible tube (e.g., 150 mm long), and a straight or angled 15 mm male connector at the distal end; it may include an integrated suction port or be provided with a microbial medical gas filter. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
096372255
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
50749756033140DeRoyal10-513010-51302023-01-31
50749756392490DeRoyalNP-6006UNP-6006U2026-01-22
50749756397808DeRoyalNP-0080LMDNP-0080LMD2026-01-22
00749756401258DeRoyalSTM2000STM20002026-01-22
50749756401352DeRoyalM60-AP500M60-AP5002026-01-22
50749756401376DeRoyalM60-AP600M60-AP6002026-01-22
50749756401383DeRoyalM60-AP601M60-AP6012026-01-22
50749756401390DeRoyalM60-AP602M60-AP6022026-01-22
50749756401482DeRoyal46-LT19S-01B46-LT19S-01B2026-01-22
50749756401437DeRoyalM70-200PM70-200P2026-01-01
50749756401444DeRoyalM70-200CM70-200C2026-01-01
50749756401451DeRoyalM70-200CNWM70-200CNW2026-01-01
50749756401468DeRoyalM70-200PNWM70-200PNW2026-01-01
50749756394418DeRoyal71-080571-08052025-08-13
50749756396641DeRoyalPH81-010400PH81-0104002025-08-13
50749756397853DeRoyalPH81-020409PH81-0204092025-08-13
50749756397860DeRoyalPH81-020412PH81-0204122025-08-13
00749756399333DeRoyal1-524A-01-CHO1-524A-01-CHO2025-07-30
00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
00749756399357DeRoyal1-524A-03-CHO1-524A-03-CHO2025-07-30

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00628101548254OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101559618OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101595708OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101599980OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101622374OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631543OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631567OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631574OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631628OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631635OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631642OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631673OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631680OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631703OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631710OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631727OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631734OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631741OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631758OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631802OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631819OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631826OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631833OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631871OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631888OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631918OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631925OhioOHIO MEDICAL, LLCBYX2026-03-23
00628101631932OhioOHIO MEDICAL, LLCBYX2026-03-23
00628101631949OhioOHIO MEDICAL, LLCBYX2026-03-23
00848530108632CPAP TubingSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-03-19