FDA.reportPublic FDA data

Deltec

Primary DI
10610586040252
Brand
Deltec
Company
ICU MEDICAL, INC.
Model
21-2481-24
Published
2016-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112407000SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERSSmiths Medical MD, Inc.2012-02-09DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30610586040256PackageGS15In Commercial Distribution
10610586040252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3061058604025630610586040256
1061058604025210610586040252

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical pipetteA manually-operated device typically used in the laboratory to withdraw, transfer, and inject discrete volumes of fluid materials. The device is typically hand-held and operates through an internal mechanism powered by the fingers; it can have a single channel or multichannel piston/cylinder pick-up assembly. The device transfers consistent volumes of liquid into one or several receptacles simultaneously (e.g., the wells of a microtitre plate). A pipette may be factory pre-set to deliver a given volume, or may have user-selectable volumes within a useful volume range. The delivered volume may be mechanically indicated.

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709197272BivonaFT26FN70NSZ233N2026-07-23
10887709198392BivonaSU26GN80NZC083N2026-07-23
10887709198408BivonaZA26GN85NSC085N2026-07-23
10887709198750BivonaSZ26GN70ZSZ114N2026-07-23
10887709198873BivonaZU26GN75NSC099N2026-07-23
10887709198941BivonaZU26GN60NGF143N2026-07-23
10887709198958BivonaZU26GN55NGF144N2026-07-23
10887709199085BivonaFU26GN35NGF169N2026-07-23
10887709199092BivonaFT26GN35NGA089N2026-07-23
10887709199108BivonaFT26GN35NGE166N2026-07-23
10887709199115BivonaST26GN40NGF165N2026-07-23
10887709199146BivonaFT26GN55NGC172N2026-07-23
10887709199153BivonaFU26GN55NGC170N2026-07-23
10887709199160BivonaFT26GN50NGC171N2026-07-23
10887709199177BivonaFU26GN40NGA178N2026-07-23
10887709199184BivonaFU26GN55NSF173N2026-07-23
10887709199207BivonaST26GN50NSC177N2026-07-23
10887709199214BivonaFT26GN30NGF174N2026-07-23
10887709199221BivonaST26GN55NSC176N2026-07-23
10887709199238BivonaFT26GN40NGE175N2026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902226485ARROWTELEFLEX INCORPORATEDDYB2026-07-22
00850064198676Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
00850064198683Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
10884450114008Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-09
10884450119799Prelude EASE™Merit Medical Systems, Inc.DYB2026-06-09
10884450114855Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-08
00850084947001Genie MAXCULTIV8 1, LLCDYB2026-05-29
G440VIZ1750MultiflexVizaramed, Inc.DYB2026-04-09
04251244502768Catapult Guide SheathContract Medical International GmbHDYB2024-08-19
04251244502775Catapult Guide SheathContract Medical International GmbHDYB2024-08-19
04251244502782Catapult Guide SheathContract Medical International GmbHDYB2024-08-19
04251244501983Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244501990Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502003Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502010Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502027Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502034Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502041Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502058Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502065Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502072Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502089Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502096Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502102Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502119Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502126Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502133Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502140Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502157Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502164Catapult Guide SheathContract Medical International GmbHDYB2023-09-01