FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756907663
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
32-2085
Device description
Saline Tubing
Published
2017-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAZTUBING, NONINVASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAZTubing, NoninvasiveGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756907663PackageGS120In Commercial Distribution
00749756907668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975690766350749756907663
00749756907668007497569076687497569076680749756907668

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration tubing setA collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. 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

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Primary DI, Brand, Company table
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14573316385367KITAZATO VACUUM LINEKITAZATO CORPORATIONGAZ2026-03-13
04573316385377KITAZATO VACUUM LINEKITAZATO CORPORATIONGAZ2026-03-13
04573316388538KITAZATO VACUUM LINEKITAZATO CORPORATIONGAZ2026-03-13
00849296016865WelmedWELMED INC.GAZ2026-02-15
00849296016872WelmedWELMED INC.GAZ2026-02-15
00849296016889WelmedWELMED INC.GAZ2026-02-15
00849296016896WelmedWELMED INC.GAZ2026-02-15
00849296016902WelmedWELMED INC.GAZ2026-02-15
00849296016919WelmedWELMED INC.GAZ2026-02-15
00849296016926WelmedWELMED INC.GAZ2026-02-15
00849296016933WelmedWELMED INC.GAZ2026-02-15
00849296016940WelmedWELMED INC.GAZ2026-02-15
00849296016957WelmedWELMED INC.GAZ2026-02-15
00849296016964WelmedWELMED INC.GAZ2026-02-15
00849296016971WelmedWELMED INC.GAZ2026-02-15
00849296016988WelmedWELMED INC.GAZ2026-02-15
00849296016995WelmedWELMED INC.GAZ2026-02-15
00849296017008WelmedWELMED INC.GAZ2026-02-15
00849296017015WelmedWELMED INC.GAZ2026-02-15
00849296017022WelmedWELMED INC.GAZ2026-02-15
00849296017039WelmedWELMED INC.GAZ2026-02-15
50885380072350CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-13
10885380172519CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172526CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172533CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172557CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172571CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172595CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
00810130455478Medco Manufacturing IncMedco Manufacturing LLCGAZ2025-09-11