DEVICE: Aero-Med (10885380184406)
Device Identifier (DI) Information
Aero-Med
CA36800
In Commercial Distribution
CA36800
AERO-MED, LLC
CA36800
In Commercial Distribution
CA36800
AERO-MED, LLC
Specimen Transport and Shipper, Medium, Common Spirit Health Only
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| No | |
| Yes | |
| Yes | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 65196 | General specimen collection kit |
A collection of 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 laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium [e.g., preservation solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| NNK | CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
f044030a-7f40-471c-a97c-0c2380a88de9
August 13, 2025
3
March 08, 2021
August 13, 2025
3
March 08, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 50885380184404 | 4 | 10885380184406 | In Commercial Distribution | CASE |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined