FDA.report

DeRoyal

Primary DI
50749756976898
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
28-3133C
Catalog number
28-3133C
Device description
Bulk Tubing Custom
Published
2021-08-23
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

Related Records

Contact Domains

Product Codes

CodeName
BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING

Product Code Classifications

CodeDeviceSpecialtyClass
BYYTube, Aspirating, Flexible, ConnectingGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50749756976898PackageGS125In Commercial Distribution
00749756976893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975697689850749756976898
00749756976893007497569768937497569768930749756976893

GMDN Terms

TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.

Sterilization Methods

Method

Contacts

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
true
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 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

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Primary DIBrandCompanyProduct codePublished
04250676716880ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-29
04250676716897ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-29
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04250381815113ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815120ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815137ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815144ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815151ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815175ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815182ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815199ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815205ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
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