Aero-Med CHBUICK6

GUDID 50885380178557

Urine Collection Kit, UA Round Tube, Integrated Container

Aero-Med, Ltd.

Urine specimen collection kit IVD Urine specimen collection kit IVD Urine specimen collection kit IVD Urine specimen collection kit IVD
Primary Device ID50885380178557
NIH Device Record Key2d6cd900-39d5-4783-86f0-51fd734144f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAero-Med
Version Model NumberCHBUICK6
Catalog NumberCHBUICK6
Company DUNS194550042
Company NameAero-Med, Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110885380178559 [Primary]
GS110885380178559 [Primary]
GS110885380178559 [Primary]
GS110885380178559 [Primary]
GS150885380178557 [Package]
Contains: 10885380178559
Package: CASE [50 Units]
In Commercial Distribution
GS150885380178557 [Package]
Contains: 10885380178559
Package: CASE [50 Units]
In Commercial Distribution
GS150885380178557 [Package]
Contains: 10885380178559
Package: CASE [50 Units]
In Commercial Distribution
GS150885380178557 [Package]
Contains: 10885380178559
Package: CASE [50 Units]
In Commercial Distribution

FDA Product Code

OIBBlood and urine collection kit (excludes HIV testing)
OIBBlood and urine collection kit (excludes HIV testing)
OIBBlood and urine collection kit (excludes HIV testing)
OIBBlood and urine collection kit (excludes HIV testing)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [Aero-Med]

50885380169852Blood Culture Kit, Direct Draw, BD Media, Cleveland Clinic Only
50810010892039Specimen Collection
50810010890936Blood Collection Pack
50810010890929Blood Collection Pack
50885380107434MD Pathology Kit
50885380104273Urine Transfer Device; Kit
10810011100043Urine Collection Kit
50810011100034200C Convenience Packaging
50810011100010Chest Tube Kit Non-Sterile
50810010892084Specimen Container; Convenience Packaging
50810010892077Fine Needle Aspiration Kit
10810010892055Hair Collection Kit DOA Testing
1081001089204872 Hour Stool Collection
10810010892017Adhesive Skin Sample Collection Kit
10810010891256CRO Supplies Kit
50810010891018Urine Transfer Device; Individually Wrapped
10810010890983Serum Separator Card
10810010890976Serum Separator Card
10810010890969Blood Collection Kit Aceva
10810010890952Blood Collection Kit Bulk
10810010890945Blood Collection Kit Bulk
50810010890912Blood Collection
10810010890907Blood Spot Collection Kit
50810010890899VPA Urine Kit
50810010890868Urine Collection Kit
50810010890851Urine Collection Kit
50810010890837ED Urine Collection Kit
50810010890820Kit; L and D Urine Collection
50810010890578Labeled EDTA Tubes
50810010890561Fine Needle Aspiration Kit
50810010890554Inherigen Kit
50810010890547Prenatal Kit
50810010890530Prenatal Kit
50810010890523Prenatal Kit
10810010890440Kit; Repackaging 455071P
10810010890433Kit; Repackaging 367964
10810010890426Kit; Repackaging 367964
10810010890419Kit; Repackaging 367861
10810010890402Kit; Repackaging 367861
10810010890372Small Direct to Patient Kit
10810010890358Large Blood Collection Kit
10810010890341Large Blood Collection Kit
10810010890334Individual Patient Pack
10810010890327Individual Patient Pack
10810010890310Individual Patient Pack
10810010890303Small NMR Blood Collection Kit
10810010890297Swab Convenience Pack
10810010890273Buccal Swab Kit
50810010890226Urine Foley Catheter Kit
50810010890219Urine Transfer Cup and Straw Kit

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.