FDA.reportPublic FDA data

Codonics Safe Label System®(SLS) 550i Point of Care Station

Primary DI
00814905020366
Brand
Codonics Safe Label System®(SLS) 550i Point of Care Station
Company
CODONICS INC.
Model
550i PCS
Device description
Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items
Published
2017-12-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSZGas-Machine, Anesthesia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSZGas-Machine, AnesthesiaAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101439000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101439000CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500PCodonics, Inc.2011-02-07BSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814905020366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814905020366008149050203668149050203660814905020366

GMDN Terms#

Term, Definition table
TermDefinition
Parenteral-nutrition management softwareA software program intended to facilitate the management of the ordering, calculation, and preparation of customizable parenteral nutrition dosages for individual patients, according to physician prescriptions. It is used in conjunction with filling and compounding machines in hospital pharmacies and compounding centres to enable the automated and systematic production of parenteral nutrition dosages.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4402431334support@codonics.com

Regulatory Flags#

DUNS number
101533727
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814905021400Codonics Safe Label System®(SLS) 610i Point of Care Station - 170C610i PCS2026-04-20
00814905021417Codonics Safe Label System®(SLS) 620i Point of Care Station - 170C620i PCS2026-04-20
00814905021431Codonics Safe Label System®(SLS) 630i Point of Care Station - 170C630i PCS2026-04-20
00814905021455Codonics Safe Label System®(SLS) 700i Point of Care Station - 170C700i PCS2026-04-20
00814905021479Safe Waste System Spectrophotometer for Pharmaceutical AnalysisSWS2026-04-20
00814905021103Codonics Safe Label System®(SLS) 600i Point of Care Station - 170C600i PCS2023-06-08
00814905020298Codonics Virtua® Controller - 73CVirtua - 73C2023-09-27
00814905020304Codonics Virtua® XR Controller - 74CVirtua XR - 74C2023-09-27
00814905020311Codonics Virtua® C Controller - 91CVirtua C -91C2023-09-27
00814905020328Codonics Virtua® Medical Disc PublisherVirtua2023-09-27
00814905020335Codonics Virtua® XR Medical Disc PublisherVirtua XR2023-09-27
00814905020342Codonics Virtua® C Controller - 90CVirtua C -90C2023-09-27
00814905020359Codonics Virtua® C/E Medical Disc PublisherVirtua C/E2023-09-27
00814905020380Codonics Virtua® Controller - 71CVirtua -71C2023-09-27
00814905020397Codonics Virtua® Controller - 75CVirtua -75C2023-09-27
00814905020403Codonics Virtua® XR Controller - 72CVirtua XR - 72C2023-09-27
00814905020410Codonics Virtua® XR Controller - 76CVirtua XR - 76C2023-09-27
00814905020427Codonics Virtua® C Controller - 92CVirtua C -92C2023-09-27
00814905020823Codonics Safe Label System®(SLS) 550i Point of Care Station - 144C550i PCS2018-10-05
00814905021059Codonics DirectVista Thermal Film, 810-DVC810-DVC2021-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814905021400Codonics Safe Label System®(SLS) 610i Point of Care Station - 170CCODONICS INC.BSZ2026-04-20
00814905021417Codonics Safe Label System®(SLS) 620i Point of Care Station - 170CCODONICS INC.BSZ2026-04-20
00814905021431Codonics Safe Label System®(SLS) 630i Point of Care Station - 170CCODONICS INC.BSZ2026-04-20
00814905021455Codonics Safe Label System®(SLS) 700i Point of Care Station - 170CCODONICS INC.BSZ2026-04-20
00816711020097ANALGESIA GAS MIXER, DIGITAL MDM DELIVERY SYSTEMPARKER-HANNIFIN CORPORATIONBSZ2025-09-24
00810085200130Ultra PC% Oral Surgery Package HACCUTRON, INC.BSZ2025-05-14
B510AM60001ADVANCED GAS-MACHINE ANESTHESIAADVANCED INSTRUMENTATIONS, INC.BSZ2025-02-07
05051977000857PenlonPENLON LTDBSZ2024-12-06
06936415980702A3 Anesthesia Delivery SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.BSZ2024-11-20
00852087007881Infinium Medical Inc.INFINIUM MEDICAL, INC.BSZ2024-05-06
00852087007898Infinium Medical Inc.INFINIUM MEDICAL, INC.BSZ2024-05-06
00816711024439DIGITAL MDM ASSY-120V(STAND MTPARKER-HANNIFIN CORPORATIONBSZ2024-04-05
00813830026979FRU, Gauge Newport O2ACCUTRON, INC.BSZ2023-10-05
00813830021141Flowmeter, CMACCUTRON, INC.BSZ2023-09-21
00813830027785Flowmeter, Digital FlushMount, INTACCUTRON, INC.BSZ2023-09-21
04048675556169Atlan A300 XLDrägerwerk AG & Co. KGaABSZ2023-09-21
04048675556176Atlan A350Drägerwerk AG & Co. KGaABSZ2023-09-21
04048675556183Atlan A350 XLDrägerwerk AG & Co. KGaABSZ2023-09-21
04048675556343Atlan A300Drägerwerk AG & Co. KGaABSZ2023-09-21
00813830026986FRU, Gauge Newport N2OACCUTRON, INC.BSZ2023-09-15
00813830026993FRU, Gauge Newport Int O2ACCUTRON, INC.BSZ2023-09-15
00813830024579Chair Conversion KitACCUTRON, INC.BSZ2023-09-14
00813830023626Ultra PC % Pkg B, InternationalACCUTRON, INC.BSZ2023-09-13
0081383002458656800 Chair Conversion KitACCUTRON, INC.BSZ2023-09-13
00813830027402Ultra PC % Package C ADJSACCUTRON, INC.BSZ2023-09-13
00813830027419Ultra DC Package C ADJSACCUTRON, INC.BSZ2023-09-13
00813830027426Digital Ultra Package C ADJSACCUTRON, INC.BSZ2023-09-13
00813830027709Digital Ultra Flushmount Package G, INTACCUTRON, INC.BSZ2023-09-13
00813830028195Digital Ultra Package C, InternationalACCUTRON, INC.BSZ2023-09-13
00813830028522Digital Ultra Package F, UKACCUTRON, INC.BSZ2023-09-13