FDA.reportPublic FDA data

Plum

Primary DI
10887787008903
Brand
Plum
Company
ICU Medical, Inc.
Model
1968328
Catalog number
1968328
Device description
LIFESHIELD LATEX-FREE MICRO SOLUSET, CONVERTIBLE PIERCING PIN, PLUMSET, FILTER, CLAVE PORT, OPTION LOK, NON-DEHP
Published
2016-09-01
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

Contact Domains#

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
K141789000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141789000PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADEHospira, Inc.2015-01-16FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20887787008900PackageGS124In Commercial Distribution
10887787008903PrimaryGS10
M33519683281SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088778700890020887787008900
1088778700890310887787008903

GMDN Terms#

Term, Definition table
TermDefinition
Bedside infusion pump, single-channelAn electrically-powered, non-ambulatory (bedside) device designed to facilitate the accurate and consistent administration of a single drug/solution which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set; it is not dedicated to a specific treatment type. It is used to supply higher pressures than those provided by gravity infusion sets or infusion controllers (e.g., typical flow range of 1 to 999 ml/hour) and delivers solutions from a standard infusion bag or bottle of fluid. It is intended primarily for use at the bedside but typically has internal batteries that enable operation, e.g., during transportation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length118Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature. Avoid Excessive Heat. Protect from Freezing

Contacts#

Phone, Email table
PhoneEmail
+1(877)946-7747uscustomercare@pfizer.com

Regulatory Flags#

DUNS number
830767898
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
10887709146966LifeShield Infusion Safety Software Suite - DFM17002-032026-10-23
10887709146973LifeShield Infusion Safety Software Suite - DLM17003-032026-10-23
10887709146980LifeShield Infusion Safety Software Suite - CDR17005-032026-10-23
10887709155050LifeShield Infusion Safety Software Suite17000-032026-10-23
10887709207230BivonaFU26JN50NSF167N2026-10-23
10887709207247BivonaFU26JN40NSF171N2026-10-23
10887709207254BivonaFT26JN35NGF170N2026-10-23
10887709207261BivonaFT26JN40NSA166N2026-10-23
10887709207278BivonaFU26JN55NGF168N2026-10-23
10887709207339BivonaFT26JN30NGE178N2026-10-23
10887709207346BivonaFT26JN35NGF174N2026-10-23
10887709207353BivonaFT26JN35NGF175N2026-10-23
10887709207360BivonaAT26JS30NGA177N2026-10-23
10887709207377BivonaAT26JS35NGA176N2026-10-23
10887709207100BivonaXU26JS40NGE159N2026-10-22
10887709207117BivonaFU26JN60NSC161N2026-10-22
10887709207124BivonaFU26JN50NGC162N2026-10-22
10887709207131BivonaHU26JS70NSC158N2026-10-22
10887709207148BivonaFT26JN40NGF157N2026-10-22
10887709207155BivonaFT26JN35NGE140N2026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10813153028329CodanCodan US CorporationFPA2026-07-17