FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756733170
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
30-I950
Catalog number
30-I950
Device description
TUBING INSUFFLATION 9.5 FT
Published
2021-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDQBOTTLE, COLLECTION, VACUUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756733170PackageGS1900In Commercial Distribution
00749756733175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975673317050749756733170
00749756733175007497567331757497567331750749756733175

GMDN Terms#

Term, Definition table
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 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
true
Expiration date on label
false
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
00850027043821Precision Medical Inc.Precision Medical, Inc.KDQ2026-02-25
00850027043838Precision Medical Inc.Precision Medical, Inc.KDQ2026-02-25
00650862199109AtriumAtrium Medical CorporationKDQ2026-02-10
20650862199158AtriumAtrium Medical CorporationKDQ2026-02-10
20650862199189AtriumAtrium Medical CorporationKDQ2026-02-10
06970462546849Stone CollectorShenzhen HugeMed Medical Technical Development Co., Ltd.KDQ2026-02-10
16970462546853Stone CollectorShenzhen HugeMed Medical Technical Development Co., Ltd.KDQ2026-02-10
10884389968109MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
10884389968123MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
10888277143029MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
10888277143517MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
00860014577536GROWNSYOak Tech LLCKDQ2026-01-28
00860014577543GROWNSYOak Tech LLCKDQ2026-01-28
00810477022272AMPLIMAMPLIM, LLCKDQ2026-01-16
00810477022289AMPLIMAMPLIM, LLCKDQ2026-01-16
00810116023769Dornier HOOVER Access SheathDORNIER MEDTECH AMERICA, INC.KDQ2026-01-14
00810116023752Dornier HOOVER Access SheathDORNIER MEDTECH AMERICA, INC.KDQ2026-01-14
10884389968079MEDLINEMEDLINE INDUSTRIES, INC.KDQ2025-11-28
06976358503880SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KDQ2025-09-17
34026704912194PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-09-17
10858276007707Polyp Trap single chamber bulkMicro-tech UsaKDQ2025-09-09
34026704911784PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-09-04
26944932721962Wellead Stone Collection BottleWell Lead Medical Co.,LtdKDQ2025-08-14
06944932726215Wellead Stone Collection BottleWell Lead Medical Co.,LtdKDQ2025-08-14
26944932726226Wellead Stone Collection BottleWell Lead Medical Co.,LtdKDQ2025-08-14
50749756394418DeRoyalDEROYAL INDUSTRIES, INC.KDQ2025-08-13
06976472080106Nasal aspiratorShenzhen Dongjiang Technology Co., Ltd.KDQ2025-07-25
06976472080113Nasal aspiratorShenzhen Dongjiang Technology Co., Ltd.KDQ2025-07-25
06976472080151Nasal aspiratorShenzhen Dongjiang Technology Co., Ltd.KDQ2025-07-25
06976472080168Nasal aspiratorShenzhen Dongjiang Technology Co., Ltd.KDQ2025-07-25