Jelco

GUDID 35019315057865

Smiths Medical ASD, Inc.

Infant limb immobilizer, reusable
Primary Device ID35019315057865
NIH Device Record Key244368b3-5038-4d36-8ff5-d0d96249d8b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameJelco
Version Model NumberLS11
Company DUNS082005361
Company NameSmiths Medical ASD, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105019315057864 [Primary]
GS135019315057865 [Package]
Contains: 05019315057864
Package: Carton [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYHSPLINT, EXTREMITY, NONINFLATABLE, EXTERNAL, STERILE
LGZWarmer, thermal, infusion fluid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-27
Device Publish Date2017-01-03

On-Brand Devices [Jelco]

30351688073598452215
503516880730114102115
303516880730004102010
303516880729974102015
30351688072980452110
30351688072973452115
30351688072966452010
50351688072953452015
10351688072542EL31915
10351688071026432215
10351688071019432115
30351688071006432110
10351688070999432015
10351688070982432010
10351688070975431915
10351688070968431910
10351688070951431815
30351688070948431810
10351688070937403005
10351688070920402605
10351688070913982512
30351688070900402705
10351688070890402515
30351688070887402315
30351688070870402215
30351688070863402115
30351688070856402015
30351688070849401915
30351688070832401815
103516880702414430-5
103516880702344430-3
10351688069818402110
30351688069805402010
30351688069799401910
10351688069788401810
30351688069362432558
10351688069351432510
10351688069344432310
30351688069331432210
10351688066558402558
30351688066545402510
30351688066538402210
30351688066521402310
3035168806559396005
3035168806558696004
103516880645094425-TB
103516880644934426-TB
103516880644864427-TB
103516880609764428-5
303516880609634429-3

Trademark Results [Jelco]

Mark Image

Registration | Serial
Company
Trademark
Application Date
JELCO
JELCO
97501738 not registered Live/Pending
JELCO, INC
2022-07-13
JELCO
JELCO
88904643 not registered Live/Pending
Smiths Medical ASD, Inc.
2020-05-07
JELCO
JELCO
88477098 not registered Live/Pending
J. E. LORTIE COMPANY LIMITED
2019-06-17
JELCO
JELCO
81001492 1001492 Dead/Cancelled
Johnson & Johnson
0000-00-00
JELCO
JELCO
77770940 3746512 Live/Registered
Smiths Medical ASD, Inc.
2009-06-30
JELCO
JELCO
75242787 2172522 Dead/Cancelled
JELCO, INC.
1997-02-18
JELCO
JELCO
73130068 1085415 Live/Registered
JOHNSON & JOHNSON
1977-06-13
JELCO
JELCO
72438236 0979039 Live/Registered
JOHNSON & JOHNSON
1972-10-13
JELCO
JELCO
72211073 0797327 Live/Registered
JOHNSON & JOHNSON
1965-02-01
JELCO
JELCO
72166482 0767143 Dead/Expired
PETRI-KINE CAMERA COMPANY, INC.
1963-04-10
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.