Jelco

Primary DI
35019315057940
Brand
Jelco
Company
Smiths Medical ASD, Inc.
Model
HC10
Published
2020-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
35019315057940PackageGS120In Commercial Distribution
15019315057946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931505794035019315057940
1501931505794615019315057946

GMDN Terms#

Term, Definition table
TermDefinition
Infant limb immobilizer, 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
082005361
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50351688508896MedexMX207752016-10-11
50351688508933MedexMX207552016-10-11
50610674800094PortexH4003PS2015-09-01
30610674802094PortexH4021PS2015-09-01
30610674802780PortexH4022PS2015-09-01
50351688500302MedexTF562016-10-13
50351688500319MedexTF552016-12-29
50351688500487MedexSM7223SC2016-10-13
50351688500555MedexSM50142017-01-03
50351688500647MedexSM50042017-01-03
50351688500654MedexSM50032017-01-03
50351688504638MedexMX8702016-10-13
50351688505031MedexMX8012016-10-13
50351688505406MedexMX7452017-02-27
50351688505413MedexMX7432016-10-13
50351688506878MedexMX4982016-10-12
50351688506922MedexMX4922016-10-12
50351688507097MedexMX457L2016-10-12
50351688507103MedexMX4572016-10-12
50351688507189MedexMX453L2016-10-12

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