FDA.reportPublic FDA data

DLP®

Primary DI
20613994846604
Brand
DLP®
Company
MEDTRONIC, INC.
Model
61000
Device description
SET 61000 PRESSURE DISPLAY 45 10PK 17L
Published
2016-06-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXSGAUGE, PRESSURE, CORONARY, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXSGauge, Pressure, Coronary, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K852232000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K852232000PRESSURE DISPLAY BOX #60000/TUBING SET #61000Dlp, Inc.1985-08-09DXS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613994846604PrimaryGS10
00613994846600Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061399484660420613994846604
00613994846600006139948466006139948466000613994846600

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length114.3Centimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
10
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169705753MyCareLink™24950JLQ2016-05-28
00763000354466Symplicity Spyral™RDN0162023-11-30
00613994391551NA6207-S52017-01-03
00613994391568NA6208-S52017-01-03
00613994391575NA6209-S52017-01-03
00613994391582NA6210-S52017-01-03
00613994397829NA6211-S52017-01-03
00643169002913Stretch™ Insertion Tool0060732016-07-02
00643169013964NA2082112017-02-02
00643169013988NA2072232017-02-03
00643169013995NA207211A2017-02-02
00643169014008NA2072112017-02-02
00643169014022NA2062232017-02-03
00643169014039NA206211A2017-02-02
00643169014046NA2062112017-02-02
00643169014053NA205211A2017-02-02
00643169014060NA2052112017-02-02
00643169014077INPUT™ TS091102A2017-02-02
00643169014084INPUT™ TS091101A2017-02-03
00643169014091INPUT™ TS090037A2017-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250413406470ABPMpro cuff for right armSOMNOmedics AGDXS2026-07-07
20763000946504DLP®MEDTRONIC, INC.DXS2024-07-18
00763000946500DLP®MEDTRONIC, INC.DXS2024-07-18
20643169880959DLP®MEDTRONIC, INC.DXS2019-03-03
20613994846628DLP®MEDTRONIC, INC.DXS2016-06-13
20613994846642DLP®MEDTRONIC, INC.DXS2016-06-13
20613994846666DLP®MEDTRONIC, INC.DXS2016-06-13
00643169200999NAMEDTRONIC, INC.DXS2016-04-28
B0663014000000PRESSURE GAUGE ISOLATOR KITNOVOSCI CORP.DXS2015-10-09
B0663014000007PRESSURE GUAGE ISOLATOR KITNOVOSCI CORP.DXS2015-10-09