Reservoir

Primary DI
00763000980856
Brand
Reservoir
Company
MEDTRONIC POWERED SURGICAL SOLUTIONS
Model
22101 A
Device description
RES 22101 A NEO FLAT DOME W/ 3.0CM VCATH
Published
2025-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LKGPort & catheter, implanted, subcutaneous, intraventricular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKGPort & Catheter, Implanted, Subcutaneous, IntraventricularNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K874498000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K874498000CSF-VENTRICULOSTOMY RESERVOIRPudenz-Schulte Medical Research Corp.1988-02-11LKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000980856PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000980856007630009808567630009808560763000980856

GMDN Terms#

Term, Definition table
TermDefinition
Cranial port/reservoirA sterile, implantable chamber intended to be connected to an intracerebral catheter for infusion/injection of materials (e.g., chemotherapeutic agents, radioisotopes) into the brain (e.g., cerebral ventricles, cystic tumours, tumour cavities); it may also be used for drainage of cerebrospinal fluid (CSF) from the ventricles and as part of a ventriculo-peritoneal/atrial shunt system. The device is implanted subcutaneously and materials infused/injected with a needle via hypodermic puncture flow into the target site through the connected catheter. It is typically a bulb-shaped device made of plastic material (e.g., polypropylene, silicone). This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
098308849
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000374976Midas Rex LegendPC7102020-10-02
00763000244859MIDAS REXPC710-R2019-07-19
00763000080174MIDAS REXPC7102019-06-08
00763000514006MIDAS REX MR8MR8-SP14MH302022-04-22
00199150001989MR8MR8-15MH20L2026-03-09
00763000545116MIDAS REX MR8IRD8502022-06-02
00763000545123MIDAS REX MR8IRD8702022-06-02
00763000487126MIDS REX MR8MR8-10BA30D2022-01-01
00763000753412ENT MR81847B20SDM2022-12-29
00763000514020MIDAS REX CURVED BURMR8-SP14MH30T2022-04-22
00763000753382ENT MR81847B20SCT2022-12-29
20763000545134ENT MR8IRD8752022-06-02
00763000030636N/A24106 A2020-04-19
00763000031107N/A22101 A2020-04-19
00643169497542NA24106 A2015-07-07
00643169579385NA22101 A2015-06-24
00613994908308NA24106 A2015-06-16
00613994908674NA22101 A2015-06-17
00763000521622MIDAS REX MR8MR8-ASDS01-R2025-08-10
20763000545103MIDAS REX MR8IRD8002022-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000980849ReservoirMEDTRONIC POWERED SURGICAL SOLUTIONSLKG2025-08-03
00763000980863ReservoirMicro Therapeutics, Inc.LKG2025-08-03
00763000028268N/AMEDTRONIC PS MEDICAL, INC.LKG2020-04-20
00763000028275N/AMEDTRONIC PS MEDICAL, INC.LKG2020-04-19
00763000030612N/AMicro Therapeutics, Inc.LKG2020-04-19
00763000030636N/AMEDTRONIC POWERED SURGICAL SOLUTIONSLKG2020-04-19
00763000031107N/AMEDTRONIC POWERED SURGICAL SOLUTIONSLKG2020-04-19
00382830055772Natus®NATUS MEDICAL INCORPORATEDLKG2020-04-03
00382830055826Natus®NATUS MEDICAL INCORPORATEDLKG2020-04-03
00382830056212Natus®NATUS MEDICAL INCORPORATEDLKG2020-04-03
00763000028237N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000028244N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000028251N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000028503N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000028510N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000028527N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000028534N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029197N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029203N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029685N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029869InnervisionMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029876InnervisionMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029883InnervisionMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029890InnervisionMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029906InnervisionMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029913InnervisionMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029920InnervisionMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000030155N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000030285N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000030292N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20