FDA.reportPublic FDA data

EDGE BIOLOGICALS INC

Primary DI
B645T06371
Brand
EDGE BIOLOGICALS INC
Company
EDGE BIOLOGICALS, INC.
Model
T0637
Device description
SALINE 0.85% 9ML
Published
2025-04-17
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JSCCulture Media, General Nutrient Broth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSCCulture Media, General Nutrient BrothMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B645T0637PrimaryHIBCC0
B645T06371Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Saline suspension medium/diluent IVDA saline solution intended to be used as a non-enriching diluent or suspension medium for microorganisms isolated from a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047927827
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
B645GS101EDGE BIOLOGICALS INCGS1012025-04-22
B645GS102EDGE BIOLOGICALS INCGS1022025-04-22
B645GS103EDGE BIOLOGICALS INCGS1032025-04-22
B6450715EDGE BIOLOGICALS INCT07152025-04-21
B6453P395EDGE BIOLOGICALS INC3P3952025-04-21
B645T0415EDGE BIOLOGICALS INCT04152025-04-21
B645T0453EDGE BIOLOGICALS INCT04532025-04-21
B645T0466EDGE BIOLOGICALS INCT04662025-04-21
B645T0481EDGE BIOLOGICALS INCT04812025-04-21
B645T0486EDGE BIOLOGICALS INCT04862025-04-21
B645T0488EDGE BIOLOGICALS INCT04882025-04-21
B645T0496EDGE BIOLOGICALS INCT04962025-04-21
B645T0577EDGE BIOLOGICALS INCT05772025-04-21
B645T0615EDGE BIOLOGICALS INCT06152025-04-21
B645T0641EDGE BIOLOGICALS INCT06412025-04-21
B645T0711EDGE BIOLOGICALS INCT07112025-04-21
B645T0713EDGE BIOLOGICALS INCT07132025-04-21
B645T0714EDGE BIOLOGICALS INCT07142025-04-21
B645T0718EDGE BIOLOGICALS INCT07182025-04-21
B645T0722EDGE BIOLOGICALS INCT07222025-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975278042516JIAOYUEJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.JSC2026-04-21
06975278042523JIAOYUEJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.JSC2026-04-21
06975278042479JIAOYUEJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.JSC2026-04-18
06975278040321JIAOYUEJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.JSC2026-03-13
06975278040093personal lubricantJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.JSC2026-02-22
06975278040109personal lubricantJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.JSC2026-02-22
00810144911496Cell ProAnalytiChem USA, Inc.JSC2025-11-26
00810144911502Cell ProAnalytiChem USA, Inc.JSC2025-11-26
00810144911519Cell ProAnalytiChem USA, Inc.JSC2025-11-26
B645T0415EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0481EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0488EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0755EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0756EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0757EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0764EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0765EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T04151EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T04811EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T04881EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T07551EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T07561EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T07571EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T07641EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T07651EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0040EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-18
B645T0041EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-18
B645T0046EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-18
B645T0047EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-18
B645T0051EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-18