FDA.reportPublic FDA data

Silhouette® Paradigm®

Primary DI
05705244008410
Brand
Silhouette® Paradigm®
Company
Unomedical A/S
Model
MMT-368600
Device description
Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
Published
2016-09-15
Public version status
Update
Distribution status
Not 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
K002138000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002138000PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380Maersk Medical A/S2000-08-29FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05705244008427PackageGS1200In Commercial Distribution
05705244008410PrimaryGS10
05705244012684Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05705244008427057052440084275705244008427
05705244008410057052440084105705244008410
05705244012684057052440126845705244012684

GMDN Terms#

Term, Definition table
TermDefinition
Electric infusion pump administration set, single-useA collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle30degree
Depth13Millimeter
Length46Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-646-4633xx@xx.xx

Regulatory Flags#

DUNS number
306032491
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05705244027176iLet FlexFG000063-092025-12-14
05705244026872iLet FlexFG000063-022025-12-14
05705244026902iLet FlexFG000063-042025-12-14
05705244026933iLet FlexFG000063-062025-12-14
05705244026964iLet FlexFG000063-082025-12-14
05705244026995iLet FlexFG000063-102025-12-14
05705244027022iLet FlexFG000063-122025-12-14
05705244027053iLet FlexFG000063-012025-12-14
05705244027084iLet FlexFG000063-032025-12-14
05705244027114iLet FlexFG000063-052025-12-14
05705244027145iLet FlexFG000063-072025-12-14
05705244027206iLet FlexFG000063-112025-12-14
05705244026865iLet FlexFG000063-022025-12-14
05705244026889iLet FlexFG000063-042025-12-14
05705244026926iLet FlexFG000063-062025-12-14
05705244026957iLet FlexFG000063-082025-12-14
05705244026988iLet FlexFG000063-102025-12-14
05705244027015iLet FlexFG000063-122025-12-14
05705244027046iLet FlexFG000063-012025-12-14
05705244027060iLet FlexFG000063-032025-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00827989008243MedSafetyHealth Care Logistics, Inc.FPA2026-07-10
00840117349841IV Administration Sets, Non-Toxic, 20 Drops/mL, 84" (213.4 cm)Dynarex CorporationFPA2026-06-30