| Primary Device ID | B6452P380 |
| NIH Device Record Key | 020d3cb8-760b-4a1d-a390-8f38f75d49de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EDGE BIOLOGICALS INC |
| Version Model Number | 2P380 |
| Company DUNS | 047927827 |
| Company Name | EDGE BIOLOGICALS, INC. |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B6452P380 [Primary] |
| JSI | Culture Media, Selective And Differential |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-15 |
| Device Publish Date | 2023-06-07 |
| B6452P075 | 2P075 |
| B6452P009 | 2P009 |
| B645T0721 | THIOGLYCOLLATE BROTH THIOGLYCOLLATE BROTH W/O INDICATOR 5ML |
| B645T0482 | NUTRIENT BROTH 10ML |
| B645T0045 | BRAIN HEART INFUSION BROTH W/ GLYCEROL 2ML |
| B6454P414 | THERMAL AGAR |
| B6454P320 | SABOURAUD DEXTROSE AGAR |
| B6454P286 | PSEUDOMONAS ISOLATION AGAR |
| B6454P202 | INHIBITORY MOLD AGAR |
| B6454P182 | ETA W/ GENTAMICIN AGAR EUGON AGAR W/ GENTAMICIN |
| B6454P124 | DERMATOPHYTE TEST MEDIUM (DTM) AGAR |
| B6454P100 | XLT-4 AGAR |
| B6454P021 | BRAIN HEART INFUSION AGAR W/ GENTAMICIN |
| B6454P019 | BACILLUS CERUS AGAR |
| B6454B070 | BILE ESCULIN / BHI 6.5% NACL BI PLATE BILE ESCULIN/BHI WITH Salt biplate |
| B6453P276 | PEA W/ SHEEP BLOOD AGAR |
| B6453P240 | MUELLER HINTON AGAR |
| B6453P190 | HEKTOEN ENTERIC AGAR |
| B6453P020 | BRAIN HEART INFUSION AGAR |
| B6452P425 | XLD AGAR |
| B6452P380 | SALMONELLA-SHIGELLA (SS) AGAR |
| B6452P285 | PLATE COUNT AGAR |
| B6452P210 | MANNITOL SALT AGAR |
| B6452P070 | BILE ESCULIN AGAR |
| B6452P069 | BISMUTH SULFITE AGAR |
| B6451R003 | TRYPTIC SOY AGAR W/ LECITHIN & POLYSORBATE 80 |
| B6451P405 | TRYPTIC SOY AGAR |
| B6451P265 | NUTRIENT AGAR |
| B6451P205 | MACCONKEY AGAR |
| B6451P180 | LEVINE EMB AGAR EOSIN METHYLENE BLUE (EMB) AGAR |
| B645T06371 | SALINE 0.85% 9ML |
| B645T06361 | SALINE 0.85% 10ML |
| B645T06311 | MIDDLEBROOK 7H11 AGAR SLANTS |
| B645T06271 | SALINE 0.85% 3ML |
| B645T06261 | SALINE 0.85% 9.9ML |
| B645T06251 | SALINE 0.85% 0.9ML |
| B645T06161 | SALINE 0.85% 5ML |
| B645T06111 | SALINE 0.85% 5ML |
| B645T06041 | SALINE 0.85% 2ML |
| B645T06031 | SALINE 0.85% 1ML |
| B645T06011 | SALINE 0.45% 3ML |
| B645T04871 | NUTRIENT BROTH 125ML |
| B645TT04481 | PHOSPHATE BUFFER 2ML |
| B645T03911 | MOTILITY TEST MEDIUM W/ IND 5ML |
| B645T03861 | MIO MEDIUM 5ML |
| B645T02361 | GN BROTH 5ML |
| B645T00041 | STAPH BROTH 5ML |
| B645PB50 | PHOSPAHTE BUFFER 50ML |
| B645GB2851 | PLATE COUNT AGAR 125ML |
| B645GB225 | NUTRIENT BROTH 225ML |