FDA.reportPublic FDA data

Biowy Freezing Bag

Primary DI
00851739007255
Brand
Biowy Freezing Bag
Company
Biowy Corporation
Model
FB1000
Device description
Biowy Freezing Bag FB1000, Max Volume: 1000 mL
Published
2021-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LPZContainer, Frozen Donor Tissue Storage

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPZContainer, Frozen Donor Tissue StorageUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1701500

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1701500

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851739007255PackageGS124In Commercial Distribution
00851739007033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851739007255008517390072558517390072550851739007255
00851739007033008517390070338517390070330851739007033

GMDN Terms#

Term, Definition table
TermDefinition
Blood/tissue storage/culture containerA durable, sterile plastic container with ports, or glass bottle, intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. The device provides a suitable closed environment to reduce the risk of contamination and, if applicable, for cell growth/viability during storage that may or may not involve freezing. A device intended for cryopreservation is typically designed for long-term storage in a freezing system. A device intended for culture is typically gas permeable and may have an inner surface that enables adherence. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius35 Degrees Celsius
Storage Environment Temperature5 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
033858426
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
00851739007040Biowy PICC CatheterPICC4SK2026-04-20
00851739007057Biowy PICC CatheterPICC5DK2026-04-20
00851739007064Biowy Tym TubeTT2026-04-20
00851739007026Biowy Freezing BagFB5002021-05-24
00851739007033Biowy Freezing BagFB10002021-05-24
00851739007002Biowy Freezing BagFB502021-05-24
00851739007019Biowy Freezing BagFB2502021-05-24
00851739007248Biowy Freezing BagFB5002021-05-24
00851739007156Biowy PICC Catheter S KitPICC4SK-S2021-05-24
00851739007163Biowy PICC Catheter S KitPICC5DK-S2021-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10816203023923PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
10816203023930PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
10816203024104PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
10816203024128PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
10816203024340PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
10816203024357PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
20816203023920PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
20816203023937PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
20816203024101PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
20816203024125PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
20816203024347PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
20816203024354PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
10816203023657PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
10816203023664PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
10816203023671PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
10816203023688PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
10816203023695PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
10816203023701PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
10816203023718PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
10816203023602PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
10816203023619PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
10816203023626PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
10816203023633PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
10816203023596PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
20816203023609PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
20816203023616PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
20816203023623PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
20816203023630PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
00817827023019Cell FreezeCHARTER MEDICAL, LTD.LPZ2021-08-23
00817827023026Cell FreezeCHARTER MEDICAL, LTD.LPZ2021-08-23