FDA UDI In Commercial Distribution 🇺🇸 United States

Sterling Medical Products

DI: 00685404002005 · Model: UK 8.0 · APOLLO MEDICAL PRODUCTS CORP.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

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Basic Information

Brand Name
Sterling Medical Products
Primary DI
00685404002005
Version / Model
UK 8.0
Company Name
APOLLO MEDICAL PRODUCTS CORP.
Labeler DUNS
116768422
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-05-20
Public Version
1
Public Version Date
2020-05-28
Public Version Status
New
Public Device Record Key
fe128fae-bdb1-4c2e-b88a-6a4e9800f849

Device Description

Urinary Collection Kit with catheter

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

GMDN Terms

Code Name
45605 Single-administration urethral catheterization kit, single-use

Identifiers

Type ID
Package 10685404002002
Primary 00685404002005

Customer Contacts

Phone
815-537-5303