| Primary Device ID | 00700812001157 |
| NIH Device Record Key | b9a1aefe-8094-432d-82d6-7f0e369af1aa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Medegen Medical Products, LLC |
| Version Model Number | H122-10 |
| Company DUNS | 055527753 |
| Company Name | MEDEGEN MEDICAL PRODUCTS, LLC |
| Device Count | 10 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00700812001157 [Primary] |
| GS1 | 10700812001154 [Unit of Use] |
| FOB | BEDPAN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-28 |
| Device Publish Date | 2020-12-20 |
| 00700812000860 | 8708TYF |
| 00700812014942 | Click Seal Base 120cc No Label 360/cs |
| 00700812014041 | Sharps: 10Qt Btl Clr Sl/Sc 12/Cs |
| 00700812002666 | Sharps: 23Qt Btl Clr Sl/Sc 4/Cs |
| 00700812002659 | Sharps: Oval 12Qt Btl Clr Sl/Sc 12/Cs |
| 00700812002642 | SHARPS: SCR CP 6.2 QT |
| 00700812002635 | Sharps: 4.7Qt Btl Clr Sl/Sc 12/Cs |
| 00700812002628 | Sharps: 1.7Qt Btl Clr 20/Cs |
| 00700812002611 | Sharps: .7Qt Btl Clr 40/Cs |
| 00700812000877 | Bedpan Fracture Gold 50/cs 12/plt |
| 00700812014348 | Bag: Bio 17X18 8mic Red/Pr 1000/cs |
| 00700812013662 | Bag: STB 6X9 2mil Clr/Cpr Zip 1000/Cs |
| 00700812013655 | BAG STB 6X9 CLR CPR TZ ZIP 1000/CS |
| 00700812012689 | Bag, STB Zip, Lab Guard 6X9 Doc Pouch, |
| 00700812012504 | Bag: STB Zip 6x9 2ml Red/Blk 1000/cs |
| 00700812012344 | BAG LD LINER 38X58 1.50MIL BLK 100/CS |
| 00700812010982 | Bag: STB 11X17.5 2.0ml clr/Pr 1000/cs |
| 00700812010609 | Bag: STB 6x9 2ml Clr Prt Zip 1000/Cs |
| 00700812010326 | Bag: Bio 11x14 1.5ml Red Pr 500/Cs |
| 00700812010180 | Bag: STB 12X15 2.0ml Pr/Red 500/cs |
| 00700812010142 | Bag: STB 6X9 Zip 2.0ml ORg/Blk 1000/cs |
| 00700812009993 | Bag: STB 6x9 2ml Zip Grn/Clr Bio 1000/cs |
| 00700812009306 | Bag: STB 6X9 2.0 ml BIO Symbol 1000/cs |
| 00700812007807 | Container ClikSeal 90cc NS Hardy 400/cs |
| 00700812007791 | Cont. ClikSeal 90cc Bulk St Hardy 200/cs |
| 00700812007784 | Cont. ClikSeal 90cc Bulk NS Hardy 200/cs |
| 00700812007647 | Spec Cont 90ml Wide St 400/cs 20/plt |
| 00700812007470 | Spacesaver 90ml 400/cs 24/plt |
| 00700812007463 | Container 90ml St 400/cs 24/plt |
| 00700812007449 | Container 120ml w/Cap NL 300/cs 20/plt |
| 00700812007432 | Container 120ml NS 300/cs 20/plt |
| 00700812007425 | Container 120ml Ong Lid St 300/cs 20/plt |
| 00700812007418 | Container 120ml St 100/cs 36/plt |
| 00700812007401 | Container 120ml St 300/cs 20/plt |
| 00700812007029 | Basin Emesis 700cc Gray 250/cs 64/plt |
| 00700812004301 | Container Spec 6.5oz Spt Trns w/oLid 500 |
| 00700812004233 | Cup Medicine Prem. 1OZ mL 5000/cs 50/plt |
| 00700812003922 | Bowl Guide Wire w/oCvr GammaStble 60/cs |
| 00700812003892 | Set Vaginal Irrigation 50/c3s 60/plt |
| 00700812003724 | Pillow Case: 22X30 Paper/Poly 100/cs |
| 00700812003717 | Cup Medicine Prem. 1oz 5000/cs 50/plt |
| 00700812003632 | Kit Spill Clean Up 16/cs |
| 00700812003625 | Kit: Bio-Haz Econo 72/cs 15/plt |
| 00700812003618 | Kit: Bio-Haz Deluxe Emerg Respo 6/cs |
| 00700812003595 | Kit: BioHaz Red-Z Emer Respo (Box) 36/cs |
| 00700812003472 | Washcloth: Wh 13.5X10 500/cs |
| 00700812003465 | Drape: Sheet Wh 36X72 50/cs |
| 00700812003243 | Pillow Case: 13X18 Paper/Poly 500/cs |
| 00700812003236 | Cup Medicine 2oz US 25/slv 1150/cs 72/pl |
| 00700812002789 | Bowl Guide Wire 4500cc Blue 20/cs 9/plt |