FDA.reportPublic FDA data

Sterling Medical Products

Primary DI
00685404001985
Brand
Sterling Medical Products
Company
APOLLO MEDICAL PRODUCTS CORP.
Model
UK 5.0
Device description
Urinary Collection Kit with Catheter
Published
2020-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10685404001982PackageGS15In Commercial Distribution
00685404001985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1068540400198210685404001982
00685404001985006854040019856854040019850685404001985

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral catheterization kit, single-useA sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
815-537-5303jodi@sterlingmedproducts.com

Regulatory Flags#

DUNS number
116768422
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00685404001084Sterling Medical Products N1752019-08-02
00685404002951Sterling Medical Products5332024-05-13
00685404001619Sterling Medical Products81082019-09-27
00685404001626Sterling Medical Products81102019-09-27
00685404001633Sterling Medical Products81112019-09-27
00685404001640Sterling Medical Products81192019-09-27
00685404001657Sterling Medical Products81202019-09-27
00685404001664Sterling Medical Products81232019-09-27
00685404001671Sterling Medical Products81282019-09-27
00685404001688Sterling Medical Products81292019-09-27
00685404001695Sterling Medical Products19542019-09-27
00685404001701Sterling Medical Products67052019-09-27
00685404001718Sterling Medical Products73452019-09-27
00685404001725Sterling Medical Products97432019-09-27
00685404001879Sterling Medical Products81212019-09-27
00685404001886Sterling Medical Products81222019-09-27
00685404002746Sterling Medical ProductsR322023-09-23
00685404002753Sterling Medical ProductsS322023-09-23
00685404002760Sterling Medical ProductsR452023-09-23
00685404002777Sterling Medical ProductsS452023-09-23