| Primary Device ID | 00857048006064 |
| NIH Device Record Key | 15e4c9af-4611-4cd5-b677-e54079dc166d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | H&H Big Cinch Abdominal Bandage |
| Version Model Number | 1 |
| Catalog Number | BC01 |
| Company DUNS | 072656713 |
| Company Name | H&H MEDICAL CORPORATION |
| 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 | false |
| 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 | 00857048006064 [Primary] |
| FQM | Bandage, Elastic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-20 |
| Device Publish Date | 2020-07-10 |
| 00857048006590 - H&H Mini 2X Bandage/Gauze Combo Pack | 2021-03-25 The bundle combines gauze for wound packing and wrapping with our smallest compression bandage. It fits in your pack easily and |
| 00857048006286 - Bolin Chest Seal | 2021-01-08 Bolin Chest Seal valved chest dressing used for sealing open chest wounds and reducing the risk of tension pneumothoraxl |
| 00857048006156 - Compact Wound Seal | 2021-01-08 Compact Wound Seal, a fully occlusive dressing folded small for sealing open chest wounds and reducing the risk of tension pneum |
| 00857048006163 - Wound Seal Duo | 2021-01-08 Wound Seal Duo, a pack of two fully occlusive hydrogel dressings for sealing multiple open chest wounds and reducing the risk of |
| 00857048006170 - Penetrating Chest Injury Kit | 2021-01-08 H&H Penetrating Chest Injury Kit, containing one Bolin Chest Seal and one Wound Seal Kit, for the treatment of entry and exit ch |
| 00857048006200 - Sterile Burn Blanket | 2021-01-08 H&H Sterile Burn Blanket, a mylar non-adherent sheet sterilized for use in wrapping large burn areas and protecting them from he |
| 00857048006217 - H&H Combat Eye Sheild | 2021-01-08 H&H Combat Eye Shield, a sterile product with an aluminum eye shield surrounded by a circle of hydrogel to hold the shield in pl |
| 00857048006279 - Wound Seal Kit | 2021-01-08 Wound Seal Kit, a fully occlusive hydrogel dressing for sealing open chest wounds and reducing the risk of tension pneumothorax |