FDA.report

NA

Primary DI
00199150080700
Brand
NA
Company
MEDTRONIC, INC.
Model
BB11E27R3
Device description
CUSTOM PACK BB11E27R3 4PK MYOTHERM2
Published
2026-05-23
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

Related Records

Contact Domains

Product Codes

CodeName
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass

Product Code Classifications

CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Premarket Submissions

SubmissionSupplement
K171979000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K171979000Tubing PackMedtronic, Inc.2017-10-27DWF

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20199150080711PackageGS14In Commercial Distribution
00199150080700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2019915008071120199150080711
00199150080700001991500807001991500807000199150080700

GMDN Terms

TermDefinition
Cardiopulmonary bypass system blood tubing setA collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature00

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
006261481
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00613994964748Goodale-Lubin™0074602016-06-05
00681490860659DLPCB140172016-05-22
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23
00199150081004NABB11J58R82026-05-23
00199150081011NABB12T50R32026-05-23
00199150081035NABB7E31R342026-05-22
00199150081042NA12D63R22026-05-22
00199150081066NA4J31R12026-05-23
00199150081707NABB11J59R92026-05-22
00199150081714NABB11U73R22026-05-23
00199150081738NABB11J16R32026-05-22
00199150081745NA9M68R12026-05-23
00199150082902NABB12W52R2026-05-22

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00199150080649NAMEDTRONIC, INC.DWF2026-05-23
00199150080694NAMEDTRONIC, INC.DWF2026-05-23
00199150081004NAMEDTRONIC, INC.DWF2026-05-23
00199150081011NAMEDTRONIC, INC.DWF2026-05-23
00199150081066NAMEDTRONIC, INC.DWF2026-05-23
00199150081714NAMEDTRONIC, INC.DWF2026-05-23
00199150081745NAMEDTRONIC, INC.DWF2026-05-23
00199150081035NAMEDTRONIC, INC.DWF2026-05-22
00199150081042NAMEDTRONIC, INC.DWF2026-05-22
00199150081707NAMEDTRONIC, INC.DWF2026-05-22
00199150081738NAMEDTRONIC, INC.DWF2026-05-22
00199150082902NAMEDTRONIC, INC.DWF2026-05-22
20199150073652NAMEDTRONIC, INC.DWF2026-03-22
20199150073676NAMEDTRONIC, INC.DWF2026-03-22
20199150073690NAMEDTRONIC, INC.DWF2026-03-22
00199150073894NAMEDTRONIC, INC.DWF2026-03-22
00199150073900NAMEDTRONIC, INC.DWF2026-03-22
20199150073928NAMEDTRONIC, INC.DWF2026-03-22
20199150074116NAMEDTRONIC, INC.DWF2026-03-22
00199150074365NAMEDTRONIC, INC.DWF2026-03-22
20763000990286NAMEDTRONIC, INC.DWF2026-03-16
00199150071623NAMEDTRONIC, INC.DWF2026-03-07
20199150071917NAMEDTRONIC, INC.DWF2026-03-07
00199150071920NAMEDTRONIC, INC.DWF2026-03-07
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00199150071944NAMEDTRONIC, INC.DWF2026-03-07
20199150072020NAMEDTRONIC, INC.DWF2026-03-07
00199150072033NAMEDTRONIC, INC.DWF2026-03-07
00199150072040NAMEDTRONIC, INC.DWF2026-03-07
00199150072347NAMEDTRONIC, INC.DWF2026-03-07