FDA.reportPublic FDA data

Extended™ Reservoir 3.0mL

Primary DI
00763000837211
Brand
Extended™ Reservoir 3.0mL
Company
MEDTRONIC MINIMED, INC.
Model
MMT-342G
Device description
RSVR MMT-342G 5PK EW 3ML US
Published
2024-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZPAID, SURGICAL, VISCOELASTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZPAid, Surgical, ViscoelasticOphthalmic3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210714000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210714000Extended ReservoirMedtronic Minimed, Inc.2022-04-06LZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000837215PackageGS15In Commercial Distribution
40763000837219PackageGS172In Commercial Distribution
00763000837211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300083721520763000837215
4076300083721940763000837219
00763000837211007630008372117630008372110763000837211

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
849626338
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150002375MiniMed AppMMT-80982026-05-25
00199150002382MiniMed AppMMT-80992026-05-25
00199150077380MiniMed FlexMMT-80622026-05-25
00199150021031MiniMed FlexMMT-80702026-05-24
00763000848149MiniMed FlexMMT-80622026-05-21
00763000848156MiniMed FlexMMT-80722026-05-21
00763000990695INFINITY™ Occipitocervical Upper Thoracic System36503152026-03-22
20763000519692Guardian™ 4 SensorMMT-7040MA2023-05-06
20763000413389Guardian™ 4 SensorMMT-7040A2023-05-06
00763000413477Guardian™ 4 SensorMMT-7040B2023-05-05
20763000519685Guardian™ 4 SensorMMT-7040PA2023-05-06
20763000273358MiniMed™ ReservoirMMT-332A2019-09-02
00199150047000MiniMed 780G Insulin PumpMMT-18842025-11-08
00199150047024MiniMed 780G Insulin PumpMMT-18842025-11-08
00199150047048MiniMed 780G Insulin pumpMMT-18942025-11-08
00199150047055MiniMed 780G Insulin PumpMMT-1894MD2025-11-08
00199150034123SFTWR MMT-6101 AHCL APP 3.1 ANDROIDMMT-61012025-09-26
00199150034130MiniMed Mobile AppMMT-61022025-09-26
00613994757197iPro™2MMT-77412014-09-25
00613994951274iPro™2MMT-77422014-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05050474755093HEALON ENDOCOAT PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2025-08-20
05050474755116HEALON DUET PRO IIJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2025-08-20
05050474807433HEALON PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2024-04-08
05050474807440HEALON PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2024-04-08
05050474807457HEALON GV PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2024-04-08
05050474807464HEALON5 PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2024-04-08
20763000837215Extended™ Reservoir 3.0mLMEDTRONIC MINIMED, INC.LZP2024-02-17
00763000837235Extended™ ReservoirMEDTRONIC MINIMED, INC.LZP2024-02-12
20763000837239Extended™ ReservoirMEDTRONIC MINIMED, INC.LZP2024-02-12
00763000837259Extended Reservoir™MEDTRONIC MINIMED, INC.LZP2024-02-12
10757770601728StableViscBausch & Lomb IncorporatedLZP2023-04-09
10757770601735TotalViscBausch & Lomb IncorporatedLZP2023-04-09
15060156070373BiolonALTACOR LIMITEDLZP2022-06-07
15060156070380BiolonALTACOR LIMITEDLZP2022-06-07
00817337000128OphthalinAnika Therapeutics, Inc.LZP2021-12-29
00866142000052AnikaviscAnika Therapeutics, Inc.LZP2021-12-29
00757770558360ClearViscBausch & Lomb IncorporatedLZP2021-05-10
05050474651654HEALON GV PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2019-05-15
05050474651425HEALON DUET PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2018-07-16
05050474636972HEALON PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2018-06-25
05050474636989HEALON PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2018-06-25
05050474636996HEALON5 PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2018-06-25
00369918000008BiolonAMRING PHARMACEUTICALS INC.LZP2018-05-17
01369918000007BiolonAMRING PHARMACEUTICALS INC.LZP2018-05-17
00380651999077DUOVISCAlcon Laboratories, Inc.LZP2017-11-14
E314421004000SignatureMaterialise NVLZP2017-07-21
04711605585224UTF Hip StemUNITED ORTHOPEDIC CORP.LZP2017-05-26
00817337000012Precision Lens OphthalmicAnika Therapeutics, Inc.LZP2017-05-18
E31442100400SignatureMaterialise NVLZP2016-09-24
00380651830042PROVISCAlcon Laboratories, Inc.LZP2015-03-31