FDA UDI In Commercial Distribution 🇺🇸 United States

McKesson

DI: 10612479223391 · Model: 16-PAHL2.5G1.0 · MCKESSON MEDICAL-SURGICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
McKesson
Primary DI
10612479223391
Version / Model
16-PAHL2.5G1.0
Company Name
MCKESSON MEDICAL-SURGICAL INC.
Labeler DUNS
023904428
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-07-20
Public Version
1
Public Version Date
2020-07-28
Public Version Status
New
Public Device Record Key
1d14d496-9aa8-49a1-8d10-7f1554dbc9e7

Device Description

Heel Incision Device NEWBORN STERILE -SAFETY LANCETS 1 mm Incision Depth x 2.5 mm Incision Length

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
FMK Lancet, Blood

GMDN Terms

Code Name
61578 Manual blood lancing device, single-use

Identifiers

Type ID
Package 20612479223404
Primary 10612479223391
Package 40612479223415