FDA.reportPublic FDA data

AV-Seal®

Primary DI
00834061001238
Brand
AV-Seal®
Company
BIOLIFE, L.L.C.
Model
DIAL001
Catalog number
DIAL001
Device description
AV-Seal® Disc
Published
2023-06-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug
QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU
QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130324000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130324000STATSEAL DISCBiolife, LLC2013-07-09QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00834061001238PackageGS125In Commercial Distribution
00834061002235PackageGS1250In Commercial Distribution
00834061000231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00834061001238008340610012388340610012380834061001238
00834061002235008340610022358340610022350834061002235
00834061000231008340610002318340610002310834061000231

GMDN Terms#

Term, Definition table
TermDefinition
Non-organic haemostatic agentA non-bioabsorbable device made of mineral and/or synthetic polymer components (e.g., smectite, potassium ferrate/hydrophilic polymer) intended for application to a bleeding external epithelial wound [i.e., skin wound or gastrointestinal (GI) mucosa wound] to facilitate local haemostasis through formation of a sealant and/or clot acceleration; it might additionally be intended to absorb bodily fluids. It is available in various forms (e.g., powder, gel, impregnated gauze) intended to be applied directly or endoscopically to the wound temporarily; it does not contain an antimicrobial agent. Disposable manual or electronic devices for application may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2.4Centimeter
Width1.2Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a clean, dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 941.360.1300customer.care@biolife.com

Regulatory Flags#

DUNS number
135872476
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00834061005236StatSeal®DT623/A2026-04-09
00834061005243StatSeal®DS624/A2026-04-09
00834061005250StatSeal®DM625/A2026-04-09
00834061005267StatSeal®DL626/A2026-04-09
00834061005274StatSeal®DX627/A2026-04-09
00834061005281StatSeal®DA628/A2026-04-09
00834061005298StatSeal®DAP629/A2026-04-09
00834061005304StatSeal®DAR630/A2026-04-09
00834061005366StatSeal®LP636/A2026-04-09
00834061005373StatSeal®LP637/A2026-04-09
00834061000040WoundSeal®CSU004CSU0042022-01-28
00834061000231AV-Seal®DIAL001DIAL0012023-06-29
00834061000217StatSeal® DE021DE0212023-06-29
00834061000255WoundSeal®DWS001DWS0012023-06-29
00834061000019WoundSeal®WSO001WSO0012022-01-28
00834061000354WoundSeal®WSO1001CWSO1001C2022-07-07
00834061000026WoundSeal®NCW001NCW0012022-01-28
00834061000057WoundSeal®NPS001NPS0012022-01-28
00834061000064StatSeal®LP006LP0062022-01-28
00834061000071StatSeal®LP007LP0072022-01-28

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00850087488723CeeportCEEPORT INC.FRO2026-08-26
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00850087488853CeeportCEEPORT INC.FRO2026-08-26
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04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
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10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
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00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
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10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29