FDA.reportPublic FDA data

Jelco

Primary DI
15019315057878
Brand
Jelco
Company
ICU MEDICAL, INC.
Model
LS12
Published
2020-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FYHSPLINT, EXTREMITY, NONINFLATABLE, EXTERNAL, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYHSplint, Extremity, Noninflatable, External, SterileGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019315057872PackageGS120In Commercial Distribution
15019315057878PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931505787235019315057872
1501931505787815019315057878

GMDN Terms#

Term, Definition table
TermDefinition
Arm procedure positioner, reusableA preformed device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., orthopaedic surgery, anaesthesia administration, blood donation, intravenous (IV) infusion, physical therapy massage]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and is typically attached or fixed onto a side rail, operation/examination table, blood donor couch, or a chair, and has adjustable height, tilt, rotation, and lock positioning capabilities. This is a reusable device.

Regulatory Flags#

DUNS number
118380146
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709194226BivonaFT26EN35NSF182N2026-05-27
10887709194233BivonaFU26EN40NGA184N2026-05-27
10887709194240BivonaFT26EN60NSA185N2026-05-27
10887709194356BivonaFT26EN40NSF186N2026-05-27
00887709008045ICU MedicalB33382017-04-17
10887709194219BivonaFU26EN60NGC168N2026-05-26
10887709194141BivonaFT26EN40NGE171N2026-05-22
10887709194158BivonaSU26EN45NGG172N2026-05-22
10887709194165BivonaFU26EN35NGF174N2026-05-22
10887709194172BivonaFT26EN40NGF176N2026-05-22
10887709194189BivonaSU26EN50NGF175N2026-05-22
10887709194196BivonaFT26EN70NSC177N2026-05-22
10887709194073BivonaHT26ES60NSC163N2026-05-21
10887709194080BivonaFT26EN35NGF164N2026-05-21
10887709194097BivonaFU26EN40NSE165N2026-05-21
10887709194103BivonaFT26EN60NGA166N2026-05-21
10887709194110BivonaFU26EN30NGE167N2026-05-21
10887709194127BivonaFU26EN30NGE170N2026-05-21
10887709194134BivonaFU26EN35NGE169N2026-05-21
00887709102460ICU Medical15687-2815687-282022-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00026072012208SCAllied Medical, LLCFYH2024-05-09
00026072022771SCAllied Medical, LLCFYH2024-05-09
00026072022788SCAllied Medical, LLCFYH2024-05-09
00026072022795SCAllied Medical, LLCFYH2024-05-09
00026072022801SCAllied Medical, LLCFYH2024-05-09
00026072022818SCAllied Medical, LLCFYH2024-05-09
00026072022825SCAllied Medical, LLCFYH2024-05-09
00026072022894SCAllied Medical, LLCFYH2024-05-09
00026072022900SCAllied Medical, LLCFYH2024-05-09
00817612020964Dale Post Surgical BraDale Medical Products, Inc.FYH2024-04-25
00861887000213INRO Surgical NailInro Medical Designs IncFYH2023-08-17
10861887000210INRO Surgical NailInro Medical Designs IncFYH2023-08-17
00817612020995Dale Strapless Bendable ArmboardDALE MEDICAL PRODUCTS, INC.FYH2020-09-14
00817612021015Dale Strapless Bendable ArmboardDALE MEDICAL PRODUCTS, INC.FYH2020-09-14
00082161503118Nice StretchBROWNMED, INC.FYH2020-08-17
00082161503125Nice StretchBROWNMED, INC.FYH2020-08-17
00082161503200Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510000Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510017Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510024Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510031Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510208Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510215Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510222Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510239Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510307Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510314Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510321Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510338Nice StretchBROWNMED, INC.FYH2020-08-17
00082161520603Nice StretchBROWNMED, INC.FYH2020-08-17