FDA UDI
In Commercial Distribution
🇺🇸 United States
Bard® Parsonnet Pulse Generator Pouches
DI: 00801741040979
·
Model: 002906
·
Bard Peripheral Vascular, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Bard® Parsonnet Pulse Generator Pouches
- Primary DI
- 00801741040979
- Version / Model
- 002906
- Catalog Number
- 002906
- Company Name
- Bard Peripheral Vascular, Inc.
- Labeler DUNS
- 135057938
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-25
- Public Version
- 3
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- baef36db-d7e4-4fe4-be33-c87a47761b7c
Device Description
Bard® Parsonnet Pulse Generator Pouch, X-Large
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
- No
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DSW | BAG, POLYMERIC MESH, PACEMAKER | Cardiovascular | 870.3650 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16038 | Implantable pulse generator mesh bag, non-bioabsorbable | An implantable woven/knitted or porous bag made from a non-bioabsorbable synthetic polymer(s) intended to envelop an implantable pulse generator (IPG) (e.g., cardiac pacemaker/defibrillator) to stabilize the implant in the subcutaneous pocket in which it is implanted; it does not contain an antimicrobial agent. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741040976 | GS1 | CA | 5 | In Commercial Distribution | |
| Primary | 00801741040979 | GS1 |
Customer Contacts
- Phone
- +1(800)321-4254
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Pouch Size, X-Large |