FDA.reportPublic FDA data

Jelco

Primary DI
05019315057864
Brand
Jelco
Company
ICU MEDICAL, INC.
Model
LS11
Published
2017-01-03
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
35019315057865PackageGS120In Commercial Distribution
05019315057864PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3501931505786535019315057865
05019315057864050193150578645019315057864

GMDN Terms#

Term, Definition table
TermDefinition
Infant limb restraint, reusableA non-rigid device, usually made of a fabric and/or plastic materials, used to temporarily render parts of an infant's body immovable, e.g., the arms and/or feet while the patient undergoes therapeutic or diagnostic interventions. It will typically be used to prevent the patient from interrupting an intravenous (IV) infusion, pulling out a catheter, or interfering with wound care. 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
10887709194585BivonaFU26EN60NGA202S2026-06-03
10887709194615BivonaFT26EN50NGA210N2026-06-03
10887709194790BivonaFT26FN35NGE013N2026-06-03
10887709194806BivonaFT26FN35NGF014N2026-06-03
10887709194813BivonaHU26FS50NGF016N2026-06-03
10887709194820BivonaFT26FN45NSA017N2026-06-03
10887709194837BivonaFT26FN30NSF018N2026-06-03
10887709194844BivonaFT26FN35NGE020N2026-06-03
10887709194851BivonaFT26FN30NSE021N2026-06-03
10887709194868BivonaSU26FN50NGF022N2026-06-03
10887709194875BivonaFT26FN35NSF023N2026-06-03
10887709194882BivonaHU26FS45NSB015N2026-06-03
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

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