| Primary Device ID | 06959385758317 |
| NIH Device Record Key | 6cb3f5bf-4b42-483f-a0b9-0ac368bc1923 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZD |
| Version Model Number | / |
| Company DUNS | 654591569 |
| Company Name | Zhende Medical Co., 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06959385758317 [Primary] |
| PQE | Ostomy Care Kit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-13 |
| Device Publish Date | 2023-07-05 |
| 06959385798924 | PE tape( Solvent adhesive) |
| 06959385793097 | Medical Mask, level 1 |
| 06959385787096 | Elastic bandage |
| 06959385787010 | gauze swabs |
| 06959385781483 | Non-surgical isolation gown--Iisolation gown |
| 06926515421106 | Medical Mask L3 |
| 06926515405687 | Island Dressing |
| 06959385781469 | Isolation Gown |
| 06959385798900 | Nonwoven tape (Solvent adhesive) |
| 06959385798887 | Nonwoven tape( Solvent adhesive) |
| 06959385798863 | Silk tape(Hot melt adhesive) |
| 06959385758317 | Two-piece Ostomy Bag |
| 06959385758300 | One-piece Ostomy Bag |
| 06926515402389 | Disposable Medical Mask |
| 06926515439521 | FOAM, ADH SIL LT W/BORDER 4"X4" 1PK ,10PK/BX , 20BX/CS |
| 06926515439491 | FOAM, ADH SIL W/BORDER 4"X4" 1PK ,10PK/BX , 20BX/CS |
| 06942273318267 | Sterile Velcro Single Velcro Close 4" x 5 yds |
| 06942273318243 | Sterile Velcro Single Velcro Close 6" x 5 yds |
| 06942273318229 | Sterile Velcro Single Velcro Close 2" x 5 yds |
| 06942273318205 | Sterile Velcro Single Velcro Close 3" x 5 yds |
| 06942273318182 | Sterile Clipped Elastic Bandage 4" x 5 yds |
| 06942273318168 | Sterile Clipped Elastic Bandage 6" x 5 yds |
| 06942273318144 | Sterile Clipped Elastic Bandage 2" x 5 yds |
| 06942273318120 | Sterile Clipped Elastic Bandage 3" x 5 yds |
| 06942273318106 | Non Sterile Double Self-Closure Double Self-Closure 4" x 11 yds |
| 06942273318083 | Sterile Double Self-Closure Double Self-Closure 4" x 5 yds |
| 06942273318069 | Non Sterile Double Self-Closure Double Self-Closure 4" x 5.5 yds |
| 06942273318045 | Sterile Double Self-Closure Double Self-Closure 6" x 5 yds |
| 06942273318021 | Non Sterile Double Self-Closure Double Self-Closure 6" x 11 yds |
| 06942273318007 | Sterile Double Self-Closure Double Self-Closure 6" x 5.5 yds |
| 06942273317970 | Non Sterile Double Self-Closure Double Self-Closure 6" x 5.5 yds |
| 06942273317963 | Sterile Double Self-Closure Double Self-Closure 6" x 11 yds |
| 06942273317949 | Sterile Double Self-Closure Double Self-Closure 3" x 5 yds |
| 06942273317925 | Non Sterile Double Self-Closure Double Self-Closure 3" x 5 yds |
| 06942273317901 | Sterile Double Self-Closure Double Self-Closure 2" x 5 yds |
| 06942273317888 | Non Sterile Double Self-Closure Double Self-Closure 2" x 5 yds |
| 06942273317864 | Non Sterile Velcro Single Velcro Close 4" x 5 yds |
| 06942273317840 | Non Sterile Velcro Single Velcro Close 6" x 5 yds |
| 06942273317826 | Non Sterile Velcro Single Velcro Close 2" x 5 yds |
| 06942273317802 | Non Sterile Velcro Single Velcro Close 3" x 5 yds |
| 06942273317789 | Non-Sterile Clipped Elastic Bandage 4" x 5 yds |
| 06942273317765 | Non-Sterile Clipped Elastic Bandage 6" x 5 yds |
| 06942273317741 | Non-Sterile Clipped Elastic Bandage 2" x 5 yds |
| 06942273317727 | Non Sterile Clipped Elastic Bandage 4" x 5.5 yds |
| 06942273317703 | Non Sterile Clipped Elastic Bandage 6" x 5.5 yds |
| 06942273317680 | Non Sterile Clipped Elastic Bandage 2" x 5.5 yds |
| 06942273317666 | Non Sterile Clipped Elastic Bandage 3" x 5.5 yds |
| 06942273317642 | Non-Sterile Clipped Elastic Bandage 4" x 4.5 yds |
| 06942273317628 | Non-Sterile Clipped Elastic Bandage 6" x 4.5 yds |
| 06942273317604 | Non-Sterile Clipped Elastic Bandage 2" x 4.5 yds |