| Primary Device ID | 00850029191018 |
| NIH Device Record Key | 8fae12e7-efb0-4c6e-a9b5-074cf1f27254 |
| Commercial Distribution Discontinuation | 2021-03-09 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | 3A MEDICAL |
| Version Model Number | S3002 |
| Company DUNS | 544515279 |
| Company Name | 3A Medical Products Co.,Ltd |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com | |
| Phone | 703-232-1615 |
| service@hilo8a.com |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Special Storage Condition, Specify | Between 0 and 0 *avoid contact with an open flame or high intensity hear source |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850029191018 [Primary] |
| FYA | Gown, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-17 |
| Device Publish Date | 2021-03-09 |
| 00850029191049 | Standard Surgical Gown, Size XX-Large. Sterile. Single Use Only. Level 3 AAMI PB70. Meets requir |
| 00850029191032 | Standard Surgical Gown, Size X-Large. Sterile. Single Use Only. Level 3 AAMI PB70. Meets require |
| 00850029191025 | Standard Surgical Gown, Size Large. Sterile. Single Use Only. Level 3 AAMI PB70. Meets requireme |
| 00850029191148 | Standard Surgical gown, Size XXLARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of AS |
| 00850029191131 | Standard Surgical gown, Size XLARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of AST |
| 00850029191124 | Standard Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM |
| 00850029191056 | Poly Reinforced Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement |
| 00850029191018 | Standard Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of AS |
| 00850029191001 | Standard Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM |
| 00850029191193 | Poly Reinforced Surgical gown, Size XXLARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requireme |
| 00850029191186 | Poly Reinforced Surgical gown, Size XLARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requiremen |
| 00850029191179 | Poly Reinforced Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement |
| 00850029191162 | Poly Reinforced Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requiremen |
| 00850029191155 | Poly Reinforced Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement |
| 00850029191117 | Standard Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of AS |
| 00850029191100 | Standard Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM |
| 00850029191094 | Poly Reinforced Surgical gown, Size XXLARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requireme |
| 00850029191087 | Poly Reinforced Surgical gown, Size XLARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requiremen |
| 00850029191070 | Poly Reinforced Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement |
| 00850029191063 | Poly Reinforced Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requiremen |
| 00850029191230 | Standard Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70 |
| 00850029191223 | Standard Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of AST |
| 00850029191216 | ULTRA Reinforced Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requireme |
| 00850029191209 | Standard Surgical gown, Size LARGE , SINGLE USE ONLY, LEVEL 2 AAMI PB70 |