DEVICE: Jelco (00351688065592)

Device Identifier (DI) Information

Jelco
96005
In Commercial Distribution

SMITHS MEDICAL ASD, INC.
00351688065592
GS1

1
137835299 *Terms of Use
No description.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Blood collection tube holder, single-use A non-sterile, hand-held cylindrical device designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor to which the user attaches a blood collection needle at one end and into which the blood collection tube is inserted at the other end; this also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
JKA Tubes, vials, systems, serum separators, blood collection
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K923090 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

c1460087-a443-49bc-8b2c-bdbed414baa6
July 06, 2018
3
January 09, 2017
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
30351688065593 50 00351688065592 In Commercial Distribution CASE
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE