FDA UDI In Commercial Distribution 🇺🇸 United States

MEDLINE

DI: 10193489140187 · Model: 88000935 · MEDLINE INDUSTRIES, INC.
Product Codes
3
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
MEDLINE
Primary DI
10193489140187
Version / Model
88000935
Catalog Number
88000935
Company Name
MEDLINE INDUSTRIES, INC.
Labeler DUNS
025460908
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-09-18
Public Version
1
Public Version Date
2023-09-26
Public Version Status
New
Public Device Record Key
fd241f0e-8c9c-4cea-900c-e5281fbe5249

Device Description

PSP-NP,1000,LB,SP,3W/FDS,GRN,SP,BNS-OEM

Device Characteristics

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KGZ ACCESSORIES, CATHETER
DTL Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
DQO Catheter, intravascular, diagnostic

GMDN Terms

Code Name
58977 Basic intravenous administration set, noninvasive

Identifiers

Type ID
Package 20193489140184
Primary 10193489140187
Package 30193489140181

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K843726 000
K884408 000
K896087 000