FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756372744
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
31-VIAL19
Catalog number
31-VIAL19
Device description
Vial With Solution
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSGCULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSGCulture Media, Non-Selective And Non-DifferentialMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756372744PackageGS150In Commercial Distribution
00749756372749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975637274450749756372744
00749756372749007497563727497497563727490749756372749

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction system collection container, single-useA sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. 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
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
B645T0466EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B645T0486EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B645T0749EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B645T0759EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B6451B265EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B6451R007EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B645GB477EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B645T0006EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B645T0246EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B6452P195EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B6454P145EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B6454P459EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B645GB285EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B645T0448EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B645T0487EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
10382902212611BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood (TSA II)BECTON, DICKINSON AND COMPANYJSG2024-08-23
16972698600408KaiBiLi Extended ViralTrans PBSHangzhou Genesis Biodetection & Biocontrol Co., LTD.JSG2024-02-05
16972698600415KaiBiLi Extended ViralTrans PBSHangzhou Genesis Biodetection & Biocontrol Co., LTD.JSG2024-02-05
30382902976425BD BBL™ Fluid Thioglycollate Medium, EnrichedBECTON, DICKINSON AND COMPANYJSG2023-11-14
18053326001021BHI BROTHCOPAN ITALIA SPAJSG2023-03-03
00848838002878REMELREMEL, INC.JSG2022-12-23
00848838002946REMELREMEL, INC.JSG2022-12-23
00848838002960REMELREMEL, INC.JSG2022-12-23
00848838003363REMELREMEL, INC.JSG2022-12-23
00848838003394REMELREMEL, INC.JSG2022-12-23
00848838003721REMELREMEL, INC.JSG2022-12-23
00848838003912REMELREMEL, INC.JSG2022-12-23
00848838004537REMELREMEL, INC.JSG2022-12-23
00848838004575REMELREMEL, INC.JSG2022-12-23
00848838004612REMELREMEL, INC.JSG2022-12-23