FDA.reportPublic FDA data

Deltec

Primary DI
10610586029998
Brand
Deltec
Company
ICU MEDICAL, INC.
Model
21-3282-24
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
K101180000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101180000GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24,Smiths Medical MD, Inc.2010-08-03FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30610586029992PackageGS112In Commercial Distribution
10610586029998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3061058602999230610586029992
1061058602999810610586029998

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
10887709208497BivonaFT26KN35NGE032N2026-11-05
10887709208503BivonaFT26KN35NSF033N2026-11-05
10887709208510BivonaST26KN80NSB035N2026-11-05
10887709208527BivonaFT26KN40NGF031N2026-11-05
10887709208572BivonaFT26KN50NGF039N2026-11-05
10887709208589BivonaST26KN80NSC040N2026-11-05
10887709208596BivonaXT26HS70NSC038N2026-11-05
10887709208602BivonaFT26KN55NGC034N2026-11-05
10887709208206BivonaHU26JS55NSB221N2026-11-04
10887709208213BivonaFT26JN40NSF243N2026-11-04
10887709208282BivonaFU26KN30NGA012N2026-11-03
10887709208299BivonaFT26KN50NGF011N2026-11-03
10887709208305BivonaFT26KN50NSC004N2026-11-03
10887709208312BivonaFT26KN40NSF007N2026-11-03
10887709208329BivonaFT26KN40NGE003S2026-11-03
10887709208336BivonaFT26KN30NGE013N2026-11-03
10887709208343BivonaXT26JS50NGC230N2026-11-03
10887709208350BivonaFU26KN35NSF018N2026-11-03
10887709208367BivonaFU26KN30NSF019N2026-11-03
10887709208374BivonaFT26KN45NGF017N2026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046964716263IV Administration SetB. BRAUN MEDICAL INC.FPA2026-11-02
10885403533822BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-23
00850017421585twiistSEQUEL MED TECH, LLCFPA2026-10-19
10885403520631BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
10885403533839BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
10885403533846BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
01081633602518WUSA6010NEOCHILD, LLCFPA2026-10-08
10612479285993McKessonMCKESSON MEDICAL-SURGICAL INC.FPA2026-10-06
10612479286013McKessonMCKESSON MEDICAL-SURGICAL INC.FPA2026-10-06
04046955765164IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-27
00884450707104Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
00884450707111Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
04046955114559IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-19
10850083986008TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986015TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986022TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986039TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10813153027339CodanCodan US CorporationFPA2026-07-31
10813153028312CodanCodan US CorporationFPA2026-07-31
10850048235196HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
10850048235264HMG IV Administration SetHartman Medical Group LLCFPA2026-07-31
20850048235193HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
00382903935314NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30