FDA.reportPublic FDA data

Suction Regulator, Stainless Steel with Improved Grip

Primary DI
05060411985018
Brand
Suction Regulator, Stainless Steel with Improved Grip
Company
DTR MEDICAL LIMITED
Model
DSRS5001
Published
2026-06-10
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
KDPRegulator, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDPRegulator, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060411985025PackageGS150In Commercial Distribution
05060411985018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060411985025050604119850255060411985025
05060411985018050604119850185060411985018

GMDN Terms#

Term, Definition table
TermDefinition
Vacuum suction regulator/regulation set, general-purposeA noninvasive device/collection of noninvasive devices designed to connect to the terminal unit (wall outlet) of a vacuum pipeline system to control the degree of negative pressure during the evacuation of fluids, mucus, or solids during a range of clinical applications (e.g., not dedicated to thoracic suction). It allows continuous and/or intermittent suction at variable levels, incorporates a manometer and controls for monitoring/adjusting the level of suction, and may include collection containers, tubing or a stand/mount; it does not include patient contact devices (e.g., handpiece/tip, catheter).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry / Keep out of Sunlight

Regulatory Flags#

DUNS number
424066509
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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05060212051042Crocodile Scissors Straight, stainless steelCSS1001-S2026-06-10
05060212051059Crocodile Scissors Curved, stainless steelCSC1001-S2026-06-10
05060212051103Crile Artery Forceps, 145mm StraightCFS2001-D2026-06-10
05060212051110Crile Artery Forceps, 145mm Curved on FlatCFC2001-D2026-06-10
05060212051196Adson Non-Toothed Forceps 120mmADS5001-S2026-06-10
05060212051202Adson Toothed Forceps 120mmATS5001-S2026-06-10
05060212051264College Dental Forceps 160mmCDF20012026-06-10
05060212051721Clamp Cover Red (Small) 50mmCCR20312026-06-10
05060212051738Clamp Cover White (Med) 120mmCCW20412026-06-10
05060212051745Clamp Cover Blue (Large) 120mmCCB20512026-06-10
05060212052094Tischler Cervical Biopsy PunchCBT10012026-06-10
05060212052100Baby Tischler Cervical Biopsy PunchCBT1001B2026-06-10
05060212052339Cusco Specula Metal SmallCMM200S2026-06-10
05060212052346Cusco Specula Metal MediumCMM200M2026-06-10
05060212052360Cusco Specula Metal LargeCMM200L2026-06-10
05060212052629Cawthorne Hook 1.5mm 90 degree blackCTH2901-D2026-06-10
05060212052636Cawthorne Straight Point blackCTP2001-D2026-06-10
05060212053466Barron Suction Handle (3Fg)BSH20032026-06-10

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Primary DI, Brand, Company table
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