FDA.report

Aero-Med

Primary DI
50810010893036
Brand
Aero-Med
Company
Aero-Med, Ltd.
Model
QUE2550
Catalog number
QUE2550
Device description
Convienince Packaging Kit for B11093-100PK
Published
2021-01-05
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
50810010893036PackageGS110In Commercial Distribution
00810010893031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5081001089303650810010893036
00810010893031008100108930318100108930310810010893031

GMDN Terms

TermDefinition
General specimen receptacle transport containerA non-sterile, portable device designed for the transportation of one or multiple clinical specimen receptacles (e.g., glass vials, bottles, tubes, slides, swabs) from the point of collection to the laboratory or between medical institutions. It is typically designed to be liquid-tight with a shock-absorbing foam liner to protect the contents from adverse conditions that could cause breakage and to absorb any escaped fluid. It is available in a variety of sizes, shapes, and materials. This is a reusable 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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
50192253068748Aero-MedCA38075BCA38075B2025-05-01
50885380208308Aero-MedCA1500ACA1500A2025-04-18
50885380183667Aero-MedCA18750ACA18750A2025-04-15
50885380207721Aero-MedCA18725BCA18725B2025-04-15
50810010894729Aero-MedQUE3325QUE33252025-04-10
50885380207707Aero-MedCA38075BCA38075B2025-04-08
50885380207714Aero-MedCA38100BCA38100B2025-04-08
50885380208063Aero-MedCA14800BCA14800B2025-04-07
50885380198715Aero-MedCA54550CA545502024-01-08
50885380207745Aero-MedCA61875CA618752025-04-02
50885380198708Aero-MedCA32250BCA32250B2024-01-08
50885380207455Aero-MedCA61175CA611752025-03-20
50885380207677Aero-MedCA61900CA619002025-03-19
50810010894774Aero-MedAMM19300AMM193002025-03-06
50885380207363Aero-MedCA59025CA590252025-03-03
50885380207448Aero-MedCA59000CA590002025-03-03
50810010894736Aero-MedAMM18850AMM188502025-02-11
50810010894743Aero-MedAMM18875AMM188752025-02-11
50885380205536Aero-MedCA60225CA602252024-10-07
50885380206823Aero-MedCA60675CA606752025-01-21

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
50810010894750Aero-MedAERO-MED, LLCNNK2025-08-13
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