Aero-Med

Primary DI
50810010894958
Brand
Aero-Med
Company
AERO-MED, LLC
Model
AMM3675F
Catalog number
AMM3675F
Device description
Patient Supply Kit
Published
2026-03-17
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

Product Codes#

Code, Name table
CodeName
PWPBlood borne pathogen response kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWPBlood Borne Pathogen Response KitGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50810010894958PackageGS14In Commercial Distribution
00810010894953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5081001089495850810010894958
00810010894953008100108949538100108949530810010894953

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/examination garment kitA collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

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
10810010891140CARDINAL HEALTHAMM542AMM5422019-04-26
00810010894991Aero-MedAMM10475AAMM10475A2026-04-07
00810010895004Aero-MedAMM12325AAMM12325A2026-04-07
10810010890990CARDINAL HEALTHFO2FO22019-04-26
10810010891027CARDINAL HEALTHAMM070AMM0702019-04-26
10810010891034CARDINAL HEALTHAMM080AMM0802019-04-26
10810010891041CARDINAL HEALTHAMM215AMM2152019-04-26
10810010891119CARDINAL HEALTHAMM521AMM5212019-04-26
10810010891164CARDINAL HEALTHAMM552AMM5522019-04-26
10810010891171CARDINAL HEALTHAMM579AMM5792019-04-26
10810010891225CARDINAL HEALTHAMM999AMM9992019-04-26
10810010891232CARDINAL HEALTHAMM1550AMM15502019-04-26
10810010891263CARDINAL HEALTHAMM1800AMM18002019-04-26
10810010891270CARDINAL HEALTHAMM1875AMM18752019-04-26
10810010891287CARDINAL HEALTHAMM1925AMM19252019-04-26
10810010891546CARDINAL HEALTHHHC100HHC1002019-04-26
10810010891294CARDINAL HEALTHAMM1950AMM19502019-04-26
10810010891300CARDINAL HEALTHAMM1951AMM19512019-04-26
10810010891317CARDINAL HEALTHAMM1952AMM19522019-04-26
10810010891324CARDINAL HEALTHAMM1953AMM19532019-04-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810010894946Aero-MedAERO-MED, LLCPWP2026-03-17
00810010894953Aero-MedAERO-MED, LLCPWP2026-03-17
50810010894941Aero-MedAERO-MED, LLCPWP2026-03-17