| Primary Device ID | 00850027193113 |
| NIH Device Record Key | ca993e88-0cb2-498c-a612-937233694e13 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Polyester Spun Swab 500ct. Pouch |
| Version Model Number | 60616 |
| Company DUNS | 042126640 |
| Company Name | Steripack (usa) Limited LLC |
| Device Count | 500 |
| 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 | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850027193113 [Package] Contains: 00850027193311 Package: Case Box [2000 Units] In Commercial Distribution |
| GS1 | 00850027193199 [Unit of Use] |
| GS1 | 00850027193311 [Primary] |
| KXG | Applicator, Absorbent Tipped, Sterile |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00850027193113]
Radiation Sterilization
[00850027193113]
Radiation Sterilization
[00850027193113]
Radiation Sterilization
[00850027193113]
Radiation Sterilization
[00850027193113]
Radiation Sterilization
[00850027193113]
Radiation Sterilization
[00850027193113]
Radiation Sterilization
[00850027193113]
Radiation Sterilization
[00850027193113]
Radiation Sterilization
[00850027193113]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-11 |
| Device Publish Date | 2022-10-03 |
| 00850027193342 - XpressCollect TM Sterile Polyester Spun Swab in Tube 1 ea. | 2022-10-11 single use, sterile pouched polyester spun swabs for specimen ciollection sampling from nasal area, i.e. Anterior nares |
| 00850027193359 - XpressCollect TM Sterile Polyester Spun Swab in Tube 100 ea. | 2022-10-11 single use, sterile pouched polyester spun swabs for specimen ciollection sampling from nasal area, i.e. Anterior nares |
| 00850027193366 - Sterile 3” Foam Swab with yellow handle V2 | 2022-10-11 single use, sterile pouched polyester spun swabs for specimen ciollection sampling from nasal area, i.e. Anterior nares |
| 00850027193373 - Sterile 3” Sterile Flocked Swab with blue handle | 2022-10-11 single use, sterile pouched polyester spun swabs for specimen ciollection sampling from nasal area, i.e. Anterior nares |
| 00850027193380 - Sterile 3” Sterile Flocked Swab with white handle | 2022-10-11 single use, sterile pouched polyester spun swabs for specimen ciollection sampling from nasal area, i.e. Anterior nares |
| 00860004112747 - Sterile Polyester Spun Swab 10 Pack | 2022-10-11 single use, sterile pouched polyester spun swabs for specimen ciollection sampling from nasal area, i.e. Anterior nares |
| 00860004112761 - Sterile Polyester Spun Swab 20 Pack | 2022-10-11 single use, sterile pouched polyester spun swabs for specimen ciollection sampling from nasal area, i.e. Anterior nares |
| 00860004112792 - Sterile Polyester Spun Swab 25 Ct. Pouch | 2022-10-11 single use, sterile pouched polyester spun swabs for specimen ciollection sampling from nasal area, i.e. Anterior nares |