FDA.reportPublic FDA data

Aero-Med

Primary DI
00810010892140
Brand
Aero-Med
Company
AERO-MED, LLC
Model
LCA355
Catalog number
LCA355
Device description
Blood Culture Collection Kit - Adult
Published
2019-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OIBBlood and urine collection kit (excludes HIV testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50810010892145PackageGS120In Commercial Distribution
00810010892140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5081001089214550810010892145
00810010892140008100108921408100108921400810010892140

GMDN Terms#

Term, Definition table
TermDefinition
Phlebotomy kitA collection of devices and supplies used in the practice of collecting blood samples. It typically consists of test tubes, racks, needles, bandages, gauze pads, and a sharps container. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
194550042
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380210891Aero-MedCA62250CA622502026-06-10
10885380213465Aero-MedCA64850CA648502026-06-10
10192253062595Aero-MedCA28600ACA28600A2022-08-26
10192253062601Aero-MedCA37125CA371252022-08-26
10192253062618Aero-MedCA37875CA378752022-08-26
10192253063561Aero-MedCA44175CA441752023-02-14
10192253063578Aero-MedCA44200CA442002023-02-14
10192253063950Aero-MedCA47175CA471752023-03-15
10192253064001Aero-MedCA48700CA487002023-10-12
10885380193255Aero-MedCA2250CCA2250C2022-07-20
10885380193262Aero-MedCA2275BCA2275B2022-07-20
10885380193538Aero-MedCA44225CA442252022-08-10
10885380193637Aero-MedCA44875CA448752022-08-24
10885380193675Aero-MedCA43775CA437752022-09-09
10885380193828Aero-MedCA44550ACA44550A2022-10-04
10885380193835Aero-MedCA44575ACA44575A2022-10-04
10885380193859Aero-MedCA45525CA455252022-10-14
10885380193965Aero-MedCA46725CA467252022-11-21
10885380194108Aero-MedCA46250CA462502022-12-15
10885380194153Aero-MedCA44900CA449002023-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885380210891Aero-MedAERO-MED, LLCOIB2026-06-10
10885380213465Aero-MedAERO-MED, LLCOIB2026-06-10
00810057230448SNT BiotechSARIS AND THINGS, INC.OIB2026-06-04
10885380212017Aero-MedAERO-MED, LLCOIB2026-06-04
10885380212024Aero-MedAERO-MED, LLCOIB2026-06-04
10885380211768Aero-MedAERO-MED, LLCOIB2026-05-06
10192253071504Aero-MedAERO-MED, LLCOIB2026-04-16
10192253061031Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061093Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061109Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061475Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061482Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061505Aero-MedAERO-MED, LLCOIB2026-02-20
10885380211188Aero-MedAERO-MED, LLCOIB2026-02-13
10885380210921Aero-MedAERO-MED, LLCOIB2026-01-20
10885380210938Aero-MedAERO-MED, LLCOIB2026-01-20
10885380210877Aero-MedAERO-MED, LLCOIB2025-12-26
10885380208935Aero-MedAERO-MED, LLCOIB2025-11-04
10885380209222Aero-MedAERO-MED, LLCOIB2025-08-26
10885380208928Aero-MedAERO-MED, LLCOIB2025-08-21
10885380208447Aero-MedAERO-MED, LLCOIB2025-06-10
10885380208461Aero-MedAERO-MED, LLCOIB2025-06-10
10194717120087Regard™ROI CPS, LLCOIB2024-10-02
10885380203657Aero-MedAERO-MED, LLCOIB2024-08-01
10885380203664Aero-MedAERO-MED, LLCOIB2024-08-01
10194717119739Regard™ROI CPS, LLCOIB2024-07-19
10194717119449Regard™ROI CPS, LLCOIB2024-05-21
10885380199165Aero-MedAERO-MED, LLCOIB2024-01-31
10885380199172Aero-MedAERO-MED, LLCOIB2024-01-31
10885380199035Aero-MedAERO-MED, LLCOIB2024-01-10