FDA.reportPublic FDA data

Level 1

Primary DI
40695085401002
Brand
Level 1
Company
ICU MEDICAL, INC.
Model
L-10
Published
2016-10-14
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
LGZWarmer, thermal, infusion fluid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGZWarmer, Thermal, Infusion FluidGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K911383000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K911383000HOTLINE FLUID WARMERLevel 1 Technologies, Inc.1991-10-17LGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10695085401001PackageGS120In Commercial Distribution
20695085401008PackageGS140In Commercial Distribution
30695085401005PackageGS1160In Commercial Distribution
40695085401002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1069508540100110695085401001
2069508540100820695085401008
3069508540100530695085401005
4069508540100240695085401002

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous line filterA sterile device designed to remove microorganisms and particulate matter from solutions in an infusion/intravenous (IV) line; it can also be used to remove air. This is a single-use device.

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709201641BivonaZT26DN50NSZ214S2026-08-27
10887709202174BivonaST26HN80ZSZ137N2026-08-27
10887709202426BivonaFT26HN45NSF207N2026-08-27
10887709202433BivonaFU26HN40NGF213N2026-08-27
10887709202440BivonaFT26HN45NGA211N2026-08-27
10887709202464BivonaFT26HN30NGE215N2026-08-27
10887709202471BivonaFT26HN35NGE214N2026-08-27
10887709202259BivonaFU26HN35NGA187N2026-08-26
10887709202266BivonaFT26HN35NGE188N2026-08-26
10887709202273BivonaFU26HN40NGA186N2026-08-26
10887709202280BivonaFT26HN35NGF189N2026-08-26
10887709202297BivonaFU26HN40NGF190N2026-08-26
10887709202303BivonaFT26HN40NSE076N2026-08-26
10887709202310BivonaFU26HN25NGE191N2026-08-26
10887709202327BivonaFT26HN60NSA192N2026-08-26
10887709202334BivonaFT26HN35NGF201N2026-08-26
10887709202341BivonaFT26HN35NGE195N2026-08-26
10887709202358BivonaST26HN55NSB202N2026-08-26
10887709202365BivonaST26HN50NSB203N2026-08-26
10887709202372BivonaFT26HN50NSF193N2026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B286DWC182464TG4B220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243064T4BR21Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TGLHMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TGMBAVT1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TMBAVT1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TMBEL220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TTS4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286SWC1518224B1Single Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286SWC151822LHNB1Single CHAMBER WARMING CABINETM.A.C. MEDICAL INC.LGZ2026-08-21
B286SWC242424GNB1Single CHAMBER WARMING CABINETM.A.C. MEDICAL INC.LGZ2026-08-21
B286DWC183074EG4BC1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074EGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074T4BAVT1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074T4BR21Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074TGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074TTS4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242464T4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242464TMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242474EGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242474TG4BR21Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242474TG4BR2SB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286243074TGMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-17
B286SWC242464GMB1single Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-14
00841027105749Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-07-24
00841027105725Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-07-12
00841027104766Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-06-02
00841027104728Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-05-12
00841027104735Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-05-12
00841027104742Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-05-12