FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756035755
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
32-197
Catalog number
32-197
Device description
Catheter
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

Product Codes#

Code, Name table
CodeName
GBWCATHETER, PERITONEAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBWCatheter, PeritonealGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756035755PackageGS130In Commercial Distribution
00749756035750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975603575550749756035755
00749756035750007497560357507497560357500749756035750

GMDN Terms#

Term, Definition table
TermDefinition
Suction system catheter, general-purposeA sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.

Sterilization Methods#

Method table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756401944DeRoyal46-LT5S-0546-LT5S-052026-05-14
00749756998857DeRoyal99-021399-02132019-11-09
00749756998864DeRoyal99-021499-02142019-11-09
00749756998871DeRoyal99-021599-02152019-11-09
00749756998888DeRoyal99-021699-02162019-11-09
00749756998901DeRoyal99-021799-02172019-11-09
00749756998918DeRoyal99-021899-02182019-11-09
00749756998925DeRoyal99-021999-02192019-11-09
00749756998956DeRoyal99-022099-02202019-11-09
00749756998963DeRoyal99-022199-02212019-11-09
00749756998970DeRoyal99-022299-02222019-11-09
00749756998642DeRoyal99-021199-02112021-05-07
00749756401685DeRoyalNP-7DAYKITUTSNP-7DAYKITUTS2026-04-02
00749756401951DeRoyal46-LT20S-0446-LT20S-042026-04-02
00749756401968DeRoyal46-LT19S-0446-LT19S-042026-04-02
00749756402033DeRoyal46-LB5546-LB552026-04-02
00749756879699DeRoyal1104SPP1104SPP2026-04-02
00749756879705DeRoyal1104MPP1104MPP2026-04-02
00749756879712DeRoyal1104LPP1104LPP2026-04-02
00749756879729DeRoyal1104XLPP1104XLPP2026-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885380208942JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380208959JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380208966JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380208973JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380208980JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380208997JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209000JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209017JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209024JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209031JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209048JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209055JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209062JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209079JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209086JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209093JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209109JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209116JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209123JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209130JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209147JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209154JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209161JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209178JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209185JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209192JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209208JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209215JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
14026704912794TAUTTELEFLEX INCORPORATEDGBW2024-06-19
14026704912800TAUTTELEFLEX INCORPORATEDGBW2024-06-19