FDA.reportPublic FDA data

Jelco

Primary DI
15019315057960
Brand
Jelco
Company
ICU MEDICAL, INC.
Model
HC12
Published
2020-03-26
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
35019315057964PackageGS120In Commercial Distribution
15019315057960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931505796435019315057964
1501931505796015019315057960

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
00887709170995ICU Medical, Inc.BAGH012026-06-02
10887709194660BivonaFP26FN45NGF003N2026-06-02
10887709194677BivonaST26EN60NTB206N2026-06-02
10887709194684BivonaST26EN60NTB207N2026-06-02
10887709194691BivonaST26EN55NTB208N2026-06-02
10887709194707BivonaST26EN55NTB209N2026-06-02
10887709194714BivonaFP26FN40NSA005N2026-06-02
10887709194721BivonaFU26FN35NSA006N2026-06-02
10887709194738BivonaFP26FN35NSA007N2026-06-02
10887709194745BivonaFT26FN35NGE008N2026-06-02
10887709194752BivonaHT26FS85NSC009N2026-06-02
10887709194769BivonaFT26FN40NGF012N2026-06-02
10887709194776BivonaFT26FN35NSE011N2026-06-02
10887709194783BivonaXT26FS50NSA010N2026-06-02
10887709193830BivonaZU26EN70NSC132N2026-06-01
10887709193847BivonaZU26EN75NSC131N2026-06-01
10887709194257BivonaSP26EN40NGE157S2026-06-01
10887709194264BivonaFF26EN55NSF148S2026-06-01
10887709194271BivonaSU26EN45NGG150N2026-06-01
10887709194288BivonaFU26EN35NSF173N2026-06-01

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