Aero-Med CA19925
GUDID 50885380176973
SurePath Cytology Convenience Kit, Health Partners Only
Aero-Med, Ltd.
Blood/tissue storage/culture container| Primary Device ID | 50885380176973 |
| NIH Device Record Key | 926ec32f-36b6-4fd9-91e9-efffe7e09af3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aero-Med |
| Version Model Number | CA19925 |
| Catalog Number | CA19925 |
| Company DUNS | 194550042 |
| Company Name | Aero-Med, Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10885380176975 [Primary] |
| GS1 | 50885380176973 [Package] Contains: 10885380176975 Package: CASE [8 Units] In Commercial Distribution |
FDA Product Code
| OKY | Cytology kit |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-29 |
| Device Publish Date | 2020-01-21 |
On-Brand Devices [Aero-Med]
| 50885380169852 | Blood Culture Kit, Direct Draw, BD Media, Cleveland Clinic Only |
| 50810010892039 | Specimen Collection |
| 50810010890936 | Blood Collection Pack |
| 50810010890929 | Blood Collection Pack |
| 50885380107434 | MD Pathology Kit |
| 50885380104273 | Urine Transfer Device; Kit |
| 10810011100043 | Urine Collection Kit |
| 50810011100034 | 200C Convenience Packaging |
| 50810011100010 | Chest Tube Kit Non-Sterile |
| 50810010892084 | Specimen Container; Convenience Packaging |
| 50810010892077 | Fine Needle Aspiration Kit |
| 10810010892055 | Hair Collection Kit DOA Testing |
| 10810010892048 | 72 Hour Stool Collection |
| 10810010892017 | Adhesive Skin Sample Collection Kit |
| 10810010891256 | CRO Supplies Kit |
| 50810010891018 | Urine Transfer Device; Individually Wrapped |
| 10810010890983 | Serum Separator Card |
| 10810010890976 | Serum Separator Card |
| 10810010890969 | Blood Collection Kit Aceva |
| 10810010890952 | Blood Collection Kit Bulk |
| 10810010890945 | Blood Collection Kit Bulk |
| 50810010890912 | Blood Collection |
| 10810010890907 | Blood Spot Collection Kit |
| 50810010890899 | VPA Urine Kit |
| 50810010890868 | Urine Collection Kit |
| 50810010890851 | Urine Collection Kit |
| 50810010890837 | ED Urine Collection Kit |
| 50810010890820 | Kit; L and D Urine Collection |
| 50810010890578 | Labeled EDTA Tubes |
| 50810010890561 | Fine Needle Aspiration Kit |
| 50810010890554 | Inherigen Kit |
| 50810010890547 | Prenatal Kit |
| 50810010890530 | Prenatal Kit |
| 50810010890523 | Prenatal Kit |
| 10810010890440 | Kit; Repackaging 455071P |
| 10810010890433 | Kit; Repackaging 367964 |
| 10810010890426 | Kit; Repackaging 367964 |
| 10810010890419 | Kit; Repackaging 367861 |
| 10810010890402 | Kit; Repackaging 367861 |
| 10810010890372 | Small Direct to Patient Kit |
| 10810010890358 | Large Blood Collection Kit |
| 10810010890341 | Large Blood Collection Kit |
| 10810010890334 | Individual Patient Pack |
| 10810010890327 | Individual Patient Pack |
| 10810010890310 | Individual Patient Pack |
| 10810010890303 | Small NMR Blood Collection Kit |
| 10810010890297 | Swab Convenience Pack |
| 10810010890273 | Buccal Swab Kit |
| 50810010890226 | Urine Foley Catheter Kit |
| 50810010890219 | Urine Transfer Cup and Straw Kit |
Trademark Results [Aero-Med]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AERO-MED 73056345 1031361 Live/Registered |
PURITAN EQUIPMENT, INC. 1975-06-27 |
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