FDA.reportPublic FDA data

Deltec

Primary DI
10610586027697
Brand
Deltec
Company
ICU MEDICAL, INC.
Model
21-2961-24
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
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021999000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021999000GRIPPER PLUS NEEDLEDeltec, Inc.2002-08-13FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30610586027691PackageGS112In Commercial Distribution
10610586027697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3061058602769130610586027691
1061058602769710610586027697

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
10887709198415BivonaST26GN30NGF103N2026-07-16
10887709198422BivonaST26GN55NSC102N2026-07-16
10887709198439BivonaST26GN45NGF098N2026-07-16
10887709198446BivonaHT26GS60NSC097N2026-07-16
10887709198453BivonaHU26GS70NSB104N2026-07-16
10887709198460BivonaSU26GN50NGF113N2026-07-16
10887709198477BivonaFT26GN35NGE112N2026-07-16
10887709198484BivonaAT26GS70NSC096N2026-07-16
10887709198163BivonaFU26GN40NGE068N2026-07-14
10887709198170BivonaFU26GN50NGC069S2026-07-14
10887709198187BivonaFT26GN60NSF067N2026-07-14
10887709198194BivonaSU26GN40NGF073N2026-07-14
10887709198200BivonaFU26GN40NGA064N2026-07-14
10887709198217BivonaFT26GN40NGF074N2026-07-14
10887709198224BivonaFT26GN45SSF075N2026-07-14
10887709198231BivonaFT26GN30NSE076N2026-07-14
10887709198248BivonaFT26GN40NSE077N2026-07-14
10887709198255BivonaFT26GN60NGF078N2026-07-14
10887709198262BivonaFP26GN35ASF079N2026-07-14
10887709198279BivonaFT26GN35NGE080N2026-07-14

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05051684018527LifeportAngiodynamics, Inc.FPA2026-06-23
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05051684018572LifeguardAngiodynamics, Inc.FPA2026-06-23
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05051684018596LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018602LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018619LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018626LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018633LifeguardAngiodynamics, Inc.FPA2026-06-23
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00634624911109Precision Delivery Bifurcated IV Extension SetQUEST MEDICAL INCFPA2022-12-19
00634624911048High-Flow Extension SetQUEST MEDICAL INCFPA2022-12-12
00634624101159Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624101258Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06