Model: ON
DI: 16973471962188
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b8310941-af5b-4471-a105-f1ad9d9ba9af
Distribution Status:
In Commercial Distribution
DUNS Number:
543029175
Device Count:
50
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
26973471962185
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
12
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
16973471962188
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
16973471962188
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
06973471962181
Item #3 - Device ID Type:
Unit of Use
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 62773
Name: General specimen collection kit IVD, clinical
Definition:
A collection of in vitro diagnostic devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered specimen receptacle with or without an additive/medium (e.g., preservation solution, microbiological medium). This is a single-use device.
FDA Product Codes
JSM
Culture Media, Non-Propagating Transport
Premarket Submissions
Submission Number:
K240235
Supplement Number:
000