AV-Seal® DIAL001
GUDID 00834061001238
AV-Seal® Disc
BIOLIFE, L.L.C.
Non-organic haemostatic agent| Primary Device ID | 00834061001238 |
| NIH Device Record Key | e1e20f72-3b08-4657-9042-3e0a8ae4d5f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AV-Seal® |
| Version Model Number | DIAL001 |
| Catalog Number | DIAL001 |
| Company DUNS | 135872476 |
| Company Name | BIOLIFE, L.L.C. |
| 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 | true |
Customer Support Contacts
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com | |
| Phone | +1 941.360.1300 |
| customer.care@biolife.com |
Device Dimensions
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
| Length | 2.4 Centimeter |
| Width | 1.2 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry place |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00834061000231 [Primary] |
| GS1 | 00834061001238 [Package] Contains: 00834061000231 Package: Case [25 Units] In Commercial Distribution |
| GS1 | 00834061002235 [Package] Contains: 00834061000231 Package: Case [250 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K130324
FDA Product Code
| FRO | Dressing, Wound, Drug |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-07 |
| Device Publish Date | 2023-06-29 |
Devices Manufactured by BIOLIFE, L.L.C.
| 00834061000217 - StatSeal® | 2023-07-07 StatSeal® Disc X-treme |
| 00834061001238 - AV-Seal® | 2023-07-07AV-Seal® Disc |
| 00834061001238 - AV-Seal® | 2023-07-07 AV-Seal® Disc |
| 00834061000255 - WoundSeal® | 2023-07-07 WoundSeal® Disc - Advanced |
| 00834061002358 - WoundSeal® | 2022-07-15 WoundSeal® Powder |
| 00834061006318 - WoundSeal® | 2022-02-07 WoundSeal® Rapid Response - 1 Application |
| 00834061000026 - WoundSeal® | 2022-02-07 WoundSeal® + Applicator - 1 Application |
| 00834061000040 - WoundSeal® | 2022-02-07 WoundSeal® Powder - 4 Applications |
| 00834061000057 - WoundSeal® | 2022-02-07 WoundSeal® MD + Applicator - 1 Application |
Trademark Results [AV-Seal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AV-SEAL 90240191 not registered Live/Pending |
Biolife, L.L.C. 2020-10-07 |
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