APIS APIS-25x25-1
GUDID 00861876000309
Advanced Wound Care Product, 25x25mm
Sweetbio, Inc.
Collagen wound matrix dressing| Primary Device ID | 00861876000309 |
| NIH Device Record Key | 818e2e9c-8581-4328-92b9-882b686d2262 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | APIS |
| Version Model Number | APIS-25x25-1 |
| Catalog Number | APIS-25x25-1 |
| Company DUNS | 080210541 |
| Company Name | Sweetbio, Inc. |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Height | 0.3 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Height | 0.3 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Height | 0.3 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Height | 0.3 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Height | 0.3 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Height | 0.3 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Height | 0.3 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Height | 0.3 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Height | 0.3 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Height | 0.3 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Height | 0.3 Millimeter |
| Length | 25 Millimeter |
| Width | 25 Millimeter |
| Height | 0.3 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00861876000309 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182725
FDA Product Code
| FRO | Dressing, Wound, Drug |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00861876000309]
Radiation Sterilization
[00861876000309]
Radiation Sterilization
[00861876000309]
Radiation Sterilization
[00861876000309]
Radiation Sterilization
[00861876000309]
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[00861876000309]
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[00861876000309]
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[00861876000309]
Radiation Sterilization
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Radiation Sterilization
[00861876000309]
Radiation Sterilization
[00861876000309]
Radiation Sterilization
[00861876000309]
Radiation Sterilization
[00861876000309]
Radiation Sterilization
[00861876000309]
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[00861876000309]
Radiation Sterilization
[00861876000309]
Radiation Sterilization
[00861876000309]
Radiation Sterilization
[00861876000309]
Radiation Sterilization
[00861876000309]
Radiation Sterilization
[00861876000309]
Radiation Sterilization
[00861876000309]
Radiation Sterilization
[00861876000309]
Radiation Sterilization
[00861876000309]
Radiation Sterilization
[00861876000309]
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[00861876000309]
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[00861876000309]
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[00861876000309]
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Radiation Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-21 |
| Device Publish Date | 2021-06-11 |
On-Brand Devices [APIS]
| 00861876000354 | Advanced Wound Care Product, 5x5cm |
| 00861876000316 | Advanced Wound Care Product, 16x16mm |
| 00861876000309 | Advanced Wound Care Product, 25x25mm |
| 00861876000385 | Advanced Wound Care Product, single pouched, 5x5cm |
Trademark Results [APIS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 APIS 98051669 not registered Live/Pending |
APIS CO., LTD 2023-06-20 |
 APIS 98051662 not registered Live/Pending |
APIS CO., LTD 2023-06-20 |
 APIS 90747173 not registered Live/Pending |
Microtech Knives, Inc. 2021-06-01 |
 APIS 88141627 5808587 Live/Registered |
Morris, Trevor 2018-10-03 |
 APIS 87667038 5650836 Live/Registered |
SweetBio, Inc. 2017-10-31 |
 APIS 87127520 5421019 Live/Registered |
Apis Partners LLP 2016-08-04 |
 APIS 86328234 5286601 Live/Registered |
Oregon Honey Products LLC 2014-07-03 |
 APIS 79271866 not registered Live/Pending |
APIS Informationstechnologien GmbH 2019-05-02 |
 APIS 78450870 not registered Dead/Abandoned |
AMS Flight USA, Inc. 2004-07-14 |
 APIS 78050581 not registered Dead/Abandoned |
Crestone International Inc. 2001-02-28 |
 APIS 75809344 2641521 Dead/Cancelled |
APIS Technical Training AB 1999-09-27 |
 APIS 75391849 2231859 Dead/Cancelled |
APIS, Inc. 1997-11-18 |
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