FDA.reportPublic FDA data

DeRoyal

Primary DI
30749756049789
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
83-000048
Catalog number
83-000048
Device description
Gas Samp Line
Published
2021-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30749756049789PackageGS125In Commercial Distribution
50749756049783PackageGS150In Commercial Distribution
00749756049788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3074975604978930749756049789
5074975604978350749756049783
00749756049788007497560497887497560497880749756049788

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia breathing circuit, single-useAn assembly of devices designed to conduct medical gases from the fresh gas supply outlet of an anaesthesia unit/workstation to the patient, typically connecting the patient, a ventilator/ventilation bag, carbon dioxide (CO2) absorber, and a monitor. It typically includes both an inhalation and exhalation route and consists of breathing tubes, a ventilation and/or reservoir bag(s), a Y-piece, connectors/adaptors, and gas sampling ports. The absorber, a one-way directional valve, and adjustable pressure limiting (APL) valve are also devices typically employed in the circuit but may not be a part of this device. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16946430425208CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425215CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425222CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425239CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425246CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425253CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425260CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425277CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425284CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425291CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425307CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425314CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425321CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425338CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425345CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425352CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425369CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425376CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425383CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425390CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425406CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425413CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425420CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425437CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425444CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
45060112316102LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-12-10
35060112316112LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-11-17
00840117340428Resp-O2 Disposable Guedel Airway, 120 mm, Adult XX-Large, Lavender Dynarex CorporationCAE2025-09-29
25060112310618LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-09-11
15060112311038LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-09-11