| Primary Device ID | M991IK722212 | 
| NIH Device Record Key | dade4fcd-b6d5-4e8e-b49c-096c089d7410 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Valved Introducer | 
| Version Model Number | Flowguard | 
| Catalog Number | IK72221 | 
| Company DUNS | 013861471 | 
| Company Name | NORFOLK MEDICAL | 
| Device Count | 1 | 
| DM Exempt | true | 
| Pre-market Exempt | false | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | true | 
| Device Combination Product | false | 
| Single Use | true | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | true | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | true | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | +1(847)674-7075 | 
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 | 
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 | 
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 | 
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 | 
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 | 
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 | 
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 | 
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 | 
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 | 
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 | 
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 | 
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 | 
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 | 
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 | 
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 | 
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 | 
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 | 
| npheil@norfolkmedical.com | 
| Length | 15 Centimeter | 
| Length | 15 Centimeter | 
| Length | 15 Centimeter | 
| Length | 15 Centimeter | 
| Length | 15 Centimeter | 
| Length | 15 Centimeter | 
| Length | 15 Centimeter | 
| Length | 15 Centimeter | 
| Length | 15 Centimeter | 
| Length | 15 Centimeter | 
| Length | 15 Centimeter | 
| Length | 15 Centimeter | 
| Length | 15 Centimeter | 
| Length | 15 Centimeter | 
| Length | 15 Centimeter | 
| Length | 15 Centimeter | 
| Length | 15 Centimeter | 
| Length | 15 Centimeter | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | M991IK722211 [Primary] | 
| HIBCC | M991IK722212 [Package] Contains: M991IK722211 Package: Box [2 Units] In Commercial Distribution | 
| DYB | INTRODUCER, CATHETER | 
| Steralize Prior To Use | true | 
| Device Is Sterile | true | 
[M991IK722212]
Ethylene Oxide
[M991IK722212]
Ethylene Oxide
[M991IK722212]
Ethylene Oxide
[M991IK722212]
Ethylene Oxide
[M991IK722212]
Ethylene Oxide
[M991IK722212]
Ethylene Oxide
[M991IK722212]
Ethylene Oxide
[M991IK722212]
Ethylene Oxide
[M991IK722212]
Ethylene Oxide
[M991IK722212]
Ethylene Oxide
[M991IK722212]
Ethylene Oxide
[M991IK722212]
Ethylene Oxide
[M991IK722212]
Ethylene Oxide
[M991IK722212]
Ethylene Oxide
[M991IK722212]
Ethylene Oxide
[M991IK722212]
Ethylene Oxide
[M991IK722212]
Ethylene Oxide
[M991IK722212]
Ethylene Oxide
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 3 | 
| Public Version Date | 2019-06-07 | 
| Device Publish Date | 2015-09-01 | 
| M991IK722212 | 10F Valved Introducer Kit | 
| M991IK522212 | 8F Valved Introducer Kit |