FDA UDI In Commercial Distribution 🇺🇸 United States

ME+1000 _ DS _ G1/2 S

DI: 08592346821026 · Model: 0735104US · GCE, s.r.o.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ME+1000 _ DS _ G1/2 S
Primary DI
08592346821026
Version / Model
0735104US
Company Name
GCE, s.r.o.
Labeler DUNS
819753190
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-07-15
Public Version
1
Public Version Date
2022-07-25
Public Version Status
New
Public Device Record Key
4ab1347e-8ca0-4561-a212-14d47a704c01

Device Description

MediEvac+ is variable control medical suction equipment powered from a vacuum source used for vacuum regulation. MediEvac+ is intended for suction of body liquids from any part of a patient's body during surgical operations, resuscitation, chest and gastritic drainage, etc. The product is not intended to be powered from: • a venturi vacuum source • a pressure gas source. The product is not intended for: • field use • direct use during thoracic drainage

Device Characteristics

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KDP Regulator, Vacuum

GMDN Terms

Code Name
44809 Vacuum suction regulator/regulation set, general-purpose

Identifiers

Type ID
Primary 08592346821026