FDA.report

Aero-Med

Primary DI
50810010894750
Brand
Aero-Med
Company
AERO-MED, LLC
Model
LCA210A
Catalog number
LCA210A
Device description
Thyroid Fna W/Rna Retain KIT
Published
2025-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NNKCONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE

Product Code Classifications

CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50810010894750PackageGS110In Commercial Distribution
00810010894755PrimaryGS10

GMDN Terms

TermDefinition
General specimen collection kitA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
194550042
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
false
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 DIBrandModelCatalogPublished
50885380211216Aero-MedCA7225ACA7225A2026-03-20
50885380211223Aero-MedLAB422520OCLAB422520OC2026-03-20
50810010894880Aero-MedAMM21200AMM212002026-03-17
50810010894927Aero-MedAMM21225AMM212252026-03-17
50810010894934Aero-MedAMM21250AMM212502026-03-17
50810010894941Aero-MedAMM21275AMM212752026-03-17
50810010894958Aero-MedAMM3675FAMM3675F2026-03-17
00810010894960Aero-MedAMM20800AMM208002026-03-17
00810010894977Aero-MedAMM20825AMM208252026-03-17
00810010894984Aero-MedAMM20850AMM208502026-03-17
50192253061039Aero-MedCA27275CA272752026-02-20
50192253061091Aero-MedCA39450CA394502026-02-20
50192253061107Aero-MedCA39075CA390752026-02-20
50192253061473Aero-MedCA39100CA391002026-02-20
50192253061480Aero-MedCA41425CA414252026-02-20
50192253061503Aero-MedCA42200CA422002026-02-20
50885380176119Aero-MedCA28550CA285502026-02-20
50885380185036Aero-MedCA37825CA378252026-02-20
50885380185067Aero-MedCA37625CA376252026-02-20
50885380185166Aero-MedCA37275CA372752026-02-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
30860013988020500 Single strip cards and 500 foil-LifelineADVANCE DX, INC.NNK2026-03-03
30860013988037500 Blood Collection Card (500 Double strip cards and 500 foil-Lifeline)ADVANCE DX, INC.NNK2026-03-03
20860013988047Advance Dx 100 Blood Collection Card (single strip cards and 100 foil)ADVANCE DX, INC.NNK2026-03-03
30860013988051Advance Dx 500 Blood Collection Card (500 single strip cards and 500 foil)ADVANCE DX, INC.NNK2026-03-03
10860013988064Advance Dx Blood Collection Card: Single strip cards - no lines on the frontADVANCE DX, INC.NNK2026-03-03
10860013988071Advance Dx Blood Collection Card: Double Strip cardsADVANCE DX, INC.NNK2026-03-03
00860013988081Advance Dx Blood Collection Card: Triple-Single Strip cardsADVANCE DX, INC.NNK2026-03-03
10860013988095Advance Dx Blood Collection Card: Double-Double Strip cardsADVANCE DX, INC.NNK2026-03-03
B24280EZDEV21000Unfilled Easy 2 Stool Extraction DeviceAMERICAN LABORATORY PRODUCTS COMPANY, LTD.NNK2026-02-02
80827989007778Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
80827989007792Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
00859410006351SalimetricsSALIMETRICS, LLCNNK2025-12-10
00859410006368SalimetricsSALIMETRICS, LLCNNK2025-12-10
06975025177478BabioJinan Babio Biotechnology Co., Ltd.NNK2025-09-29
040669160437422.0ml SC Micro Tube protein LBSarstedt Aktiengesellschaft & Co.KGNNK2025-09-25
04066916044534SCMTube 0,5 mlSarstedt Aktiengesellschaft & Co.KGNNK2025-09-25
50810010894897Aero-MedAERO-MED, LLCNNK2025-09-11
00860013988005Advance Dx 100 Blood Collection CardADVANCE DX, INC.NNK2025-08-28
00860013988012Blood Specimen Return BagADVANCE DX, INC.NNK2025-08-28
50810010894767Aero-MedAERO-MED, LLCNNK2025-08-13
00810185250011TherapakTherapak LLCNNK2025-08-11
00810185250219TherapakTherapak LLCNNK2025-08-11
00810185250356TherapakTherapak LLCNNK2025-08-11
00810185250615TherapakTherapak LLCNNK2025-08-11
00810185250653TherapakTherapak LLCNNK2025-08-11
00810185250578TherapakTherapak LLCNNK2025-08-04
00810185250059TherapakTherapak LLCNNK2025-08-04
G669CNBOX1CNS0Crow's Nest Biopsy Catchment SystemCorramedical Inc.NNK2025-07-09
G669CNBOX4CNS1Crow's Nest Biopsy Catchment SystemCorramedical Inc.NNK2025-07-09
00840216128842CARDINAL HEALTH Asp Global, LLCNNK2025-06-17